At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

The Director, Quality Assurance is primarily responsible for developing and implementing strategies for quality oversight across all Affiliate sites within Alcon's Quality & Regulatory Affairs. You will ensure compliance with quality standards, manage quality events, and oversee complaint handling.

Specifics Include:

• Lead and direct teams to develop and implement strategies for departmental success and alignment with company goal
• Ensure compliance with quality standards and drive continuous improvement initiatives
• Manage departmental resources and make key decisions
• Guide non-conformance investigations with a structured approach to root cause analysis and problem-solving
• Lead audit preparation and manage external audits by Health Authorities and Notified Bodies
• Oversee all Quality-related activities at the country level, ensuring compliance with regulatory standards and global requirements
• Oversee quality control activities for finished products and handle product complaints
• Develop and oversee processes for an effective Quality System, includingself-inspections, supplier qualifications, corrective and preventive action (CAPA) processes, and Standard Operating Procedure (SOP) compliance
• Promote a strong Quality Culture and work closely with commercial partners and leadership teams to drive compliance as a strategic business platform
• Ensure compliance with market authorization, Good Manufacturing Practice(GMP), International Organization for Standardization (ISO) 13485, Good Distribution Practice (GDP), and local requirements
• Review and approve documentation for medicinal products and medical devices
• Ensure Good Practice (GxP) suppliers are qualified and monitored, and manage market actions
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, and completing required training
• Contribute to the overall compliance of the organization through individual job requirements
• Lead quality reviews with leadership teams, oversee key quality indicators at both country and regional levels, ensure each country’s quality plans align with regional and global standards, and managing escalations to the Global Quality Compliance function
• Oversees monthly quality performance by tracking and submitting KQI metrics, managing quality risk assessments, preparing reports for the CSCQ Head, and maintaining ongoing surveillance to support business continuity
• Oversee the end‑to‑end complaint handling operations, including timely intake, assessment, follow‑up, and routing of technical complaints and Adverse Events for all Alcon medical device products, ensuring compliance with local and international regulatory requirements
• Drive a strong quality and compliance culture across the region by promoting best practices, ensuring consistent application of complaint handling processes, and supporting continuous improvement of quality systems
• Lead and develop the complaint handling team, providing guidance on investigations, overseeing case triage, and managing escalations such as product replacements and refund requests to ensure efficient and accurate resolution
• Ensures strong people and capability development by driving talent development and succession planning, managing direct reports’ performance and compliance, overseeing training completion, and providing ongoing leadership and mentorship to the team
• This role also requires regular regional travel to support country teams, oversee activities, and ensure consistent implementation of quality standards
  

Education:                      Bachelor’s Degree in Life Sciences, Pharmacy, Engineering or other scientific discipline

Languages:                     English Proficiency

       Knowledge/ Fluency of at least one other language preferred

Experience:

• Minimum 15 years of experience in Quality Assurance, 10 years of people leadership in the medical device industry with people management experience in a matrix environment.
• Experience working in a multinational company or across multiple countries in the APAC region.
• Proven track record of developing and implementing quality assurance strategies and programs.
• Strong understanding of regulatory requirements and industry standards related to quality assurance (e.g., ISO 9001, ISO 13485, GMP, QSD and other industry standards that may apply).
• Excellent leadership and communication skills, with the ability to motivate and inspire teams to achieve quality objectives.
• Analytical mindset with strong problem-solving skills, able to lead root cause analysis and CAPA initiatives.
• Broad understanding of global expectations of Health Authorities in the GxP regulated area.
• Exposure to manufacturing operations and /or quality assurance, country organizations or commercial operations.
• Knowledge and experience in forecasting software and demonstrated proficiency in Microsoft suites.

Why join Alcon?

- Join a global leader with a rich history of innovation and excellence in eye care.

- Be part of a collaborative and supportive team culture that values diversity and inclusion.

- Enjoy a competitive compensation package and opportunities for career advancement.

- Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.

If you're ready to take the next step in your career and lead a dynamic team towards success, we want to hear from you! Apply now and join us in shaping the future of eye care at Alcon.

Alcon Careers

See your impact at alcon.com/careers

Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support our people’s career ambitions. We pledge to make Prudential a place where you can Connect, Grow, and Succeed.

This position will support the Head of Product Excellence & Transformation in driving the overall end-to-end product development projects and continuous improvement in the overall product development process and transformation.

The individual is also the central point of contact for the assigned products/projects to ensure all processes are in place, coordinate its implementation and ensuring proper governance are in place.

This will include but not limited to, supporting the launch of more innovative products with greater speed to meet the needs of our customers and distributors. This position will report into the Head of Product Excellence & Transformation.

Job Description

• Lead product development process and facilitate cross-functional teams to execute the agreed product plan, while ensuring compliance with the product development policy and SOPs

• Ensure effective communication between the Product management team and our core internal partners in Finance, Technology, Customer Experience, Life Operations, Marketing and Distribution

• Provides regular communication and updates on progress ensure visibility and action on the key risks and issues

• Collaborate with the Product managers and other stakeholders to manage timeline and track implementation progress for the entire product development cycle, from pre-launch to post-launch

• Ensure completion of product launch signoffs, record management of all relevant documents and post-launch review under Product Management

• Identify areas of optimisation and improvements by deconstructing issues and proposing solutions for future improvement

Who we are looking for

Competencies & Personal Traits

• Exhibit ability to deliver effective communication and excellent interpersonal skills

• Possess strong leadership qualities and a mind towards excellence

• Analytical and strong problem-solving abilities

• Dynamic individual who strives in fast moving environment

• Strong analytical, quantitative, problem solving, communication (written and verbal), presentation, and relationship management skills; with a high degree of tact.

Working Experience

• Diploma / Degree with between 5 to 10 years of relevant experience with successful track records

• Prior life insurance product development and implementation experience would be preferred

Education

• Diploma/Degree in Finance/Business/Project Management relevant fields of studies

Prudential is an equal opportunity employer. We provide equality of opportunity of benefits for all who apply and who perform work for our organisation irrespective of sex, race, age, ethnic origin, educational, social and cultural background, marital status, pregnancy and maternity, religion or belief, disability or part-time / fixed-term work, or any other status protected by applicable law. We encourage the same standards from our recruitment and third-party suppliers taking into account the context of grade, job and location. We also allow for reasonable adjustments to support people with individual physical or mental health requirements.

Responsibilities

• Set up from scratch a QA environment for an ERP software product in enterprise asset management and corporate property management. 

• Set up components necessary for various QA tests, including automated regression tests, smoke tests, integration tests, performance tests, vulnerability scans and regression tests. 

• Develop, document, execute and track test plans based on software requirements and technical specifications.

• Accurately record and clearly document actual results in relation to expected results

• Maintain organized records of test results and generate historical analysis of test results

• Document unexpected anomalies identified in testing, with instructions on how to reproduce the anomaly

• Assist in the development and refinement of product and software requirements.

• Communicate with the product and project teams on quality issues.

• Work with product and project teams to ensure that the software applications are fully tested.

Essential Skills and Experience

• At least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma or Professional Degree in Engineering (Computer/Telecommunication), Computer Science/Information Technology or equivalent.

• Experienced with QA tools, such as Selenium (in Java), Appium, Cucumber

• Familiarity with QA tools such as TestRails and JMeter is a plus

• Familiarity with CI servers such as Jenkins is a plus.

• Familiarity with issue trackers such as Jira or Gitlab is a plus.

• Familiarity with technologies: web applications, cloud services, virtual machines, security, HTML5, jQuery, mobile (iOS/Android).

• Familiarity with scanning tools such as Black Duck, OWASP Zap, OWASP Dependency Tracker, SonarQube is a plus.

• Relevant domain knowledge is a plus: Finance, Leasing, Procurement, Maintenance Management.

• Good communication skills.

• Strong interest in quality assurance and software engineering.

• Ability to work effectively in a dynamic working environment.

 Benefits:

• 16 hours of Flexi Timeoff

• Me Days: additional 3 days of annual leave for qualifying employees

• Engaging, fun & inclusive culture

• High performance recognition program and perks

About Us

From the day we opened our doors, MRI Software has built flexible, game-changing real estate software that powers thriving communities and helps make the world a better place to live, work and play. Fulfilling that mission is only possible because of one thing: exceptional people. People like you!  

Our people-first approach to PropTech is defining a new industry standard for client experiences that, quite frankly, can’t be duplicated. Experiences that deliver real value every day. And we know those experiences begin with our people.  

We believe MRI is more than just a workplace; it’s a connected community of people who truly feel they belong. Whether we’re investing in employee resource groups or providing tailored resources for each person to reach their full potential, we’re passionate about creating a work environment that makes you excited to show up every single day.  

At MRI, one of our core values is to strive to amaze.  From the intelligent solutions we create to the culture we cultivate, that’s our goal every day. Because that’s what industry leaders do. Whether you’re joining as a new Pride member or rejoining us after a short time away, your talent is vital to us, our partners and our clients. 

Amazing growth requires amazing employees. Are you up to the challenge?   

We know confidence gap and imposter syndrome can get in the way of meeting remarkable candidates, so please don’t hesitate to apply. We’d love to hear from you!   

MRI is proud to be an inclusive employer. We welcome and celebrate diversity across all backgrounds, including ethnicity, religion, sexual orientation, gender identity, disability, age, military, veteran status and more. 

We believe that Belonging is a direct result of Diversity, Equity, and Inclusion. Those values are woven into the fabric of who we are and are foundational to our continued success. Come and see for yourself! 

The Senior Lead Engineer – Technical Assurance is responsible for independently planning, managing, directing, and controlling the delivery of required engineering quality deliverables, ensuring alignment with specified requirements, timelines, and budgets. This role also plays a key part in the development and continuous improvement of the company’s corporate technical documents by incorporating lessons learned from the lifecycle of company facilities (FPSO) and integrating new technologies. Additionally, the Senior Lead Engineer manages changes to corporate technical documents throughout the facilities’ lifecycle and ensures the quality of engineering deliverables through continuous assurance and improvement initiatives.

Major Roles and Responsibilities:

• Support the overall activities of corporate technical experts/authorities.

• Provide feedback on technical findings to the respective discipline expert/authority and assist in updating the latest company’s corporate technical documents.

• Coordinate the validation and analysis of lessons learned issues.

• Contribute to the improvement and optimization of discipline workflow processes, as requested.

• Facilitate discussions with suppliers to drive continuous improvement of company’s corporate technical documents.

Job Requirements:

• Bachelor of Engineering or Master of Engineering.

• Minimum of 15 years of relevant experience in discipline engineering within the oil and gas sector for Bachelor’s degree holders, or a minimum of 14 years for Master’s degree holders.

• Lead level detailed engineering experience on at least one FPSO project and familiarity with market practices in the oil and gas sector.

• Proficient in applicable industry standards, software, specifications, and procedures relevant to the functional area.

Competencies:

• Comprehensive understanding of the company’s corporate design policy and philosophy, with the ability to review and verify compliance of company’s corporate technical documents with these principles.

• Familiarity with Engineering work processes and procedures across the lifecycle of facilities (FPSO or equivalent) with the capability to suggest engineered solutions to maximize lifecycle value.

• Ability to make sound decisions that align with company’s corporate design policy and philosophy, even in cases of conflicting stakeholder interests.

• Open-mindedness to new ideas and factual information.

• Strong interpersonal skills to engage in open discussions with inter-discipline and inter-company individuals, ensuring technically sound decisions are made

We are looking for a ASSISTANT QUALITY CONTROL to support quality control for hardware devices integrated with our software systems.This role is ideal for someone who is hands-on, detail-oriented, and interestedin testing how hardware and software work together in real-world environments.You will work closely with engineers and senior QA members to ensure reliabledevice performance, system stability, and overall product quality.

Key Responsibilities

• Perform manual testing on hardware devices integrated with software applications
• Verify device functionality, connectivity, and data accuracy across different scenarios
• Test hardware–software interactions, including setup, configuration, and firmware updates
• Execute test cases and test procedures for system, integration, and regression testing
• Identify, document, and track defects related to hardware, firmware, or software behavior
• Re-test issues after fixes to ensure proper resolution
• Assist in preparing and maintaining test cases, test reports, and QA documentation
• Support basic hardware setup, troubleshooting, and test environment preparation
• Participate in sprint reviews and QA discussions with cross-functional teams

Requirements & Qualifications

• Diploma or Degree in Computer Science, Information Technology, Electronics, Mechatronics, or a related field (or equivalent training)
• Basic understanding of software testing concepts and SDLC
• Interest in hardware, devices, or embedded systems
• Strong attention to detail and ability to follow test procedures accurately
• Willingness to learn hardware testing processes and tools
• Good communication skills to clearly report issues and observations

What We Offer

• Hands-on exposure to real hardware–software integrated systems
• Collaborative, cross-functional working environment

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a Qualification Engineer lead commissioning, qualification, and validation (CQV) activities for HVAC systems, cleanrooms, and critical utilities within a GMP-regulated pharmaceutical environment.

The role will focus on end-to-end qualification lifecycle execution, ensuring compliance with EU GMP Annex 15, ASTM E2500, and industry best practices.

Key Responsibilities

• Commissioning & Qualification Execution
  - Support CQV lifecycle activities for HVAC, cleanrooms, and utilities systems (e.g., PW, WFI, Clean Steam, compressed air).
  - Execute IQ, OQ, and PQ protocols for facilities and utilities systems.
  - Participate in commissioning activities including system walkdowns and punch listing.
  - Perform functional testing and verification of system performance.
• Documentation & Protocol Development
  - Develop and/or execute qualification documents: URS (review), SIA (System Impact Assessment), Risk Assessments / Criticality Assessments
  - DQ, IQ, OQ, PQ protocols and reports
  - Ensure traceability through RTM (Requirements Traceability Matrix)
• HVAC & Cleanroom Qualification
  Perform or support:
  - Airflow visualization (smoke studies)
  - HEPA filter integrity testing (PAO/DOP)
  - Air velocity and air change rate verification
  - Temperature and humidity mapping
  - Room pressure cascade verification
• Utilities Qualification
  - Support qualification of:
  - Water systems (PW/WFI loops)
  - Clean steam systems
  - Compressed gases (CDA, nitrogen, oxygen)
  - Execute sampling and testing activities in collaboration with QA/QC teams
• Stakeholder Coordination
  Work closely with:
  - Engineering / Facilities teams
  - Vendors and system integrators
  - QA/Validation teams
  - Support FAT/SAT activities where required
• GMP Compliance & Quality
  - Ensure all activities comply with:
  - cGMP requirements
  - Data integrity (ALCOA+) principles
  - Support deviations, CAPA, and change control activities

Required Qualifications

• Education
  Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related discipline)
• Experience
  ~5 years of relevant CQV/Validation experience in pharmaceutical or biotech industry
• Hands-on experience in
  - HVAC / cleanroom qualification
  - Utilities systems qualification
  - Technical Skills
• Familiar with
  - EU GMP Annex 15
  - ASTM E2500
  - ISPE Baseline Guides (Volume 5 – Commissioning & Qualification)
• Strong understanding of
  - HVAC systems and cleanroom classifications (Grade A–D)
  - Utilities systems design and operation
• Soft Skills
  - Strong documentation and technical writing skills
  - Good stakeholder management and communication skills
  - Ability to work independently and in cross-functional teams

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About the Team:

Shared Game Services (SGS) provides core platform services to all games published by Garena. Services include but are not limited to authentication, payment, and mobile SDK.

We are a dedicated and passionate team of product managers and engineers committed to building a platform that is scalable and robust for high volume, while ensuring reliable and localized user experience for our users.

Job Description:

This is a 6 months full-time onsite role based in Singapore as part of the GRIT Programme. The GRaduate Industry Traineeships (GRIT) Programme is an initiative by Workforce Singapore (WSG)  that offers fresh graduates with traineeship opportunities across various sectors.

• Operate and maintain the daily operations of the gaming product from configuration, quality assurance, live environment handling (including bugs and hacks), and operational evaluation

• Coordinate configuration & QA tasks between different offices

• Collaborate with both local and global stakeholders in resolving product-related problems

Job Requirements:

• Graduated or graduating in 2024 and 2025 with a Bachelor’s degree in Computer Science, or a related field; or graduated earlier and completed National Service in 2024 or 2025

• Singapore Citizen or Singapore Permanent Resident

• Basic understanding of software testing concepts, including test case design and defect reporting

• Hands-on experience performing manual testing and using common QA tools (e.g., TestRail, Postman)

• Ability to run simple SQL queries for data validation and support basic troubleshooting

• Introduction to automation testing concepts and willingness to learn scripting frameworks

• Ability to document test results clearly and communicate issues effectively with the team

FSSC 22000 Certified Food Manufacturing Company

Looking for Quality Assurance Executive / Manager

Location: Pandan Area

Working Hours : Monday to Friday 8.30am to 5.30pm.

Candidate must be independent and initiative to ensure company adhere to food regulations and certifications requirements. Experience with ISO 22000/ FSSC 22000 requirements is preferred.

We are seeking a lead to oversee Razer Software organization’s data governance and software compliance initiatives. This role bridges AI product development/engineering and corporate compliance, ensuring that our software products, big data, and AI systems are trustworthy, compliant, and aligned with business and regulatory standards. The successful candidate will work closely with Razer Software Engineering teams to project manage execution of AI and data governance implementations while still enabling rapid innovation and development.

Job Responsibilities

• Lead AI governance at the intersection of product, project management, and compliance.

• Responsible for establishing and maintaining robust data governance frameworks that promote data security, quality, and accessibility on a scale.

• Define policies and best practices for ethical AI development, transparency, accountability, and fairness.

• Partner with the Data Compliance and InfoSecurity teams to align Razer Software AI governance with enterprise data privacy, security, and retention standards.

• Ensure AI systems respect data minimization, consent, and cross-border data transfer rules.

• Collaborate with AI/ML engineers and product managers to embed governance principles into the AI development lifecycle.

• Provide hands-on guidance on model documentation, explainability, and audit readiness.

• Conduct AI risk assessments and establish controls for systems with business-critical or regulatory implications.

• Coordinate with SOX/Internal Audit teams if AI models are used in financial reporting or internal controls.

• Project Manage joint audits, risk assessments, and regulatory inquiries.

• Establish dashboards and reporting structures to track AI compliance posture.

Qualifications

• Bachelor’s or Master’s in Computer Science, Data Science, Law, Policy, or related field.

• 5+ years’ experience in AI governance, compliance, or technology policy.

• Familiarity with AI/ML development processes, lifecycle management, and emerging AI regulations.

• Strong understanding of data protection frameworks (GDPR, CCPA, PDPA) and corporate compliance requirements.

• Experience leading with cross-functional teams (engineering, product, legal, compliance). Project Management experience preferred.

• Excellent communication, stakeholder management, and policy writing skills.

• Game industry experience is an advantage.

Education & Experience

• BA/BS from an accredited educational institution or equivalent experience.

Job Overview:

• Upkeep QSHE Integrated Management System (IMS)

• Ensure IMS policy implementation

Responsibilities and Duties:

• Maintain integrated management system including but not limited to ISO9001, ISO14001 and ISO45001.

• Promote, organize and conduct meetings and activities including IMS Management review and Kaizen Program.

• Organize and conduct IMS inspection and audit.

• Plan and co-ordinate internal and external audits.

• Attend and support customer, supplier, authority and third-party enquiries, meeting, audit and other related matters.

• Ensure PIC take prompt resolution on non-conformities / observations, through risk consideration and effective identification of root causes, preventive and /or corrective actions.

• Monitor, track and review of action plans and reports.

• Initiate or propose improvement recommendation on any gaps or discrepancy.

• Review, research and contribute to the development of QMS initiatives.

• Role for Document Controller - Documents control on department and system documentation, which includes electronic copy in department shared drive and Intranet.

• Support team administrative function.

Added advantage

• Experience in Business Continuity Management (BCM), Good Distribution Practice for Medical Devices (GDPMDS) and Food Safety System Certification (FSSC)

Experience and Qualifications:

• Diploma / Degree in Engineering and QMS related field with min 3 years of relevant experience

• Team player, good interpersonal and communication skills, able to work independently

• Good knowledge in ISO related management systems

• Willing to travel between work sites (i.e Tuas, Jurong Island)

• Attention to detail

• A proactive approach to identifying system gaps and implementing corrective actions.

• Capability to manage multiple audit schedules and improvement projects simultaneously.

• Excellent communication and interpersonal skills

• Must have a proven records of long-term commitment and stability in his/her previous roles.

Work Arrangement: 5 days’ work week, from 8.00am to 5.45pm

We are seeking a Production Line Incoming / Outgoing Inspector (QC) to join our operations team at Hong Food Enterprise Pte Ltd. As an integral part of our quality assurance and control operations, you will be responsible for inspecting incoming raw materials and outgoing finished products to ensure they meet our stringent quality standards.

Job Responsibilities

·      Inspect and verify incoming raw materials for specifications, dimensions, and visual quality to ensure compliance with quality standards and requirements

·      Perform final and routine quality inspections on finished products prior to delivery

·      Document inspection findings and maintain detailed quality control records

·      Identify and troubleshoot quality issues, recommending corrective actions as needed

·      Perform sampling sessions of finished products

·      Collaborate with the warehouse and operations teams to implement quality improvements

·      Ensure compliance with company quality systems and procedures and assist in audit requirements

·      Provide training and guidance to staff on quality control procedures

Job Requirements

·      Minimum2–3 years of experience in quality inspection within a manufacturing environment, preferably as a Production Line Inspector or QC Technician

·      Strong understanding of quality control principles, methods and tools

·      Excellent attention to detail and problem-solving skills

·      Proficient in reading and interpreting specifications and quality standards

·      Good communication and teamwork attitude to collaborate effectively with cross-functional teams

·      Ability to work in a fast-paced environment

• Receiving, transferring and dispatching parts/materials
• Examine incoming parts/materials for damage/shortages and take necessary action
• Report any errors or faults of products/goals to superiors
• Assemble the products to the required specifications and standards
• Other related tasks when required

Job Requirements:

• Able to stand for long hours
• Able to carry up to 30kg
• Able to work in cold environment

12-hrs Shift

(Fix Shift)

Day shift : 7am to 7pm

Night shift : 7pm to 7am

Require to work one weekend every week

4334 work arrangement

Key Job Purpose:

The Quality Management (QM) Specialist is to support the QMR in ensuring the organization and its affiliates adhere to all applicable local, regulatory and quality standards associated with Enterprise Risk Management. As Subject Matter Expert (SME) for Enterprise Risks per ISO31000 and other ISO Standards for QMS, such as ISO13485, ISO14971, ISO27001, ISO14001 and WSH regulations.

The role serves to maintain a high standard of compliance, effectiveness, and continuous improvement throughout the organization's identified risks. The role will coordinate with Process Owners and appointed Risk Management PICs in Affiliates, monitor identified risks are managed in an effectiveness and timely manner. Report the progress of Enterprise Risks to Risk Management Committee in a biyearly manner.

Job Description

Risk Management

• Coordinate and work with Process Owners to address and manage the identified risks, including the execution of their effective controls.
• Ensure effectiveness of risk control measures are executed by Process Owners where documented evidence indicated in the Risk Register are available and uploaded.
• Follow-up with QMR and relevant HODs on new processes or products or business model which may an impact to operational and governance processes.
• Analyse and do trending of enterprise risks within SAP and across the region which requires escalation or proposed sources of improvement to QMR. .
• Support QMR in coordinating the Risk Management Committee meeting at SAP in biyearly manner. Assist to prepare updates and follow up actions from the Risk Management Committee meeting.
• Extend consistent practices of Enterprise Risk Management to Affiliates.
• SME for Risk Management and provide training on Risk Managements to SAP and affiliates.

Audit Support (Internal and external)

• Assist in the planning, execution, and follow-up of internal audits, ensuring compliance with regulatory standards and company policies.
• Support external audits by coordinating audit activities, preparing documentation, and ensuring audit readiness associated with Enterprise Risks
• Ensure that audit findings associated with Enterprise Risks are addressed through effective corrective actions and continuous improvement.
• Perform analysis trending on Corporate Audit findings for all affiliates in SAP and share result to QMR for reporting to Top Management.

 Environmental & WSH Support

• Support in coordinating with relevant stakeholders and assessing the impact of environmental / WSH information to the organization.
• Identify environmental issues that impact the organization, associated risks are included in Legal Risk Register and control measures are effectively put in place.

Job Requirements

• Diploma or Degree in a relevant field
• Minimum 2 years of experience in a Quality Assurance role within the Medical Devices industry
• Certified Internal Auditor for ISO 13485, ISO 9001, ISO 31000 and/or ISO 14001
• Strong knowledge of ISO standards (ISO 13485, ISO 9001, ISO 27001, ISO 14001, ISO 31000)
• Understanding of Environmental Management Systems (EMS)
• Knowledge of Workplace Safety and Health practices
• Proficient in Microsoft Office applications
• Experience in risk management activities, data trending, and analysis

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QA Validation professional provides quality oversight, review, and approval of validation and qualification activities to ensure compliance with GMP, regulatory expectations, and internal quality systems. This role ensures that validation deliverables are scientifically sound, risk-based, and inspection-ready, while supporting cross-functional project execution in a GMP-regulated environment.

Key Responsibilities

• Provide QA oversight for equipment, facility, utility, process, and cleaning validation and qualification activities
• Ensure validation approaches align with GMP, data integrity principles, and regulatory guidelines (e.g., FDA, EMA, PIC/S).
• Review validation strategies to ensure compliant, risk-based execution.
• Review and approve validation lifecycle documentation, including:
  - Validation Master Plan (VMP)
  - Risk assessments (e.g., FMEA, SRA)
  - URS, DQ, IQ, OQ, PQ
  - Cleaning validation protocols and reports
• Computer System Validation (CSV) documents, where applicable
• Ensure validation documentation is complete, traceable, and audit-ready
• Review and assess validation-related deviations, non-conformances, and investigations.
• Ensure appropriate root cause analysis and CAPA implementation.
• Support change control activities and assess validation impact.
• Support internal, customer, and regulatory inspections related to validation scope.
• Act as a QA validation subject matter representative during audits.
• Support timely closure of validation-related audit observations.
• Collaborate closely with Engineering, CQV, Manufacturing, QC, IT, and external vendors.
• Provide QA guidance during project phases, including new equipment introduction, upgrades, and revalidation.
• Support project timelines while maintaining compliance.
• Contribute to continuous improvement of validation and QA processes.
• Support updates to SOPs, templates, and validation standards.
• Promote a strong quality culture and right-first-time mindset.

Required Qualifications

• Diploma or Bachelors degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• 3–8+ years of experience in QA Validation, CQV, or Quality Assurance within GMP-regulated environments.
• Hands-on experience reviewing validation documentation for:
  - Process equipment
  - Utilities (e.g., WFI, clean steam, compressed gases)
  - Facilities and cleanrooms
  - Cleaning validation
• Experience with Computer System Validation (CSV) is an advantage.
• Strong understanding of GMP, data integrity, and validation lifecycle concepts.
• Familiarity with FDA, EMA, and PIC/S regulatory expectations.
• Strong documentation review and compliance mindset.
• Ability to challenge constructively while enabling project delivery.
• Good stakeholder engagement and communication skills.
• Detail-oriented, structured, and inspection-focused.
• Comfortable working in project-based and fast-paced environments.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.