Total 3 job vacancies by No Deviation Pte. Ltd.

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 QC Personnel will be responsible for supporting day-to-day Quality Control laboratory activities, including testing, documentation, method validation support, data review, and compliance with GMP requirements. The role requires hands-on experience with laboratory systems such as GLIMS, Veeva, and SAP, as well as experience in analytical method validation activities.

Key Responsibilities

• Perform routine QC testing for raw materials, intermediates, finished products, stability samples, and/or environmental monitoring samples, as applicable
• Execute laboratory testing in accordance with approved SOPs, test methods, specifications, and GMP requirements.
• Ensure all laboratory activities are completed accurately, timely, and in compliance with data integrity expectations.
• Support sample receipt, testing coordination, result entry, and laboratory documentation.
• Support analytical method validation, verification, transfer, and qualification activities.
  
• Execute validation protocols and document results in accordance with approved acceptance criteria.
  
• Assist in the preparation, review, and closure of method validation protocols, reports, deviations, and supporting documentation.
  
• Support troubleshooting of analytical methods and laboratory investigations where required.
• Use GLIMS for sample management, test assignment, result entry, and laboratory workflow tracking.
• Use Veeva for document management, SOP retrieval, document review, training, and quality records where applicable.
• Use SAP for material/sample-related transactions, inventory checks, batch information retrieval, or quality-related processes.
• Ensure proper documentation practices in line with ALCOA+ principles and GMP expectations.
• Support laboratory investigations, OOS/OOT investigations, deviations, CAPA, and change control activities.
• Ensure timely escalation of abnormal results, laboratory issues, equipment issues, or documentation discrepancies.
• Participate in internal audits, external inspections, and laboratory readiness activities.
• Maintain laboratory areas, equipment, reagents, standards, and records in an inspection-ready state
• Support calibration, maintenance, and qualification readiness of laboratory equipment.
• Assist in laboratory process improvements, system updates, and workflow optimization.
• Work closely with QA, Manufacturing, MSAT, Validation, and Supply Chain teams to support product release and compliance requirements.

Required Qualifications

• Diploma or Degree in Chemistry, Pharmaceutical Science, Biotechnology, Microbiology, Life Sciences, or related discipline.
• Minimum 2 to 5 years of QC laboratory experience in a pharmaceutical, biologics, medical device, or GMP-regulated environment.
• Experience with method validation, method verification, or method transfer is required.
• Hands-on experience with laboratory or quality systems such as GLIMS, Veeva, and SAP.
  
• Experience in QC testing, laboratory documentation, investigations, and GMP compliance.
• Familiar with GMP, GDP, data integrity, ALCOA+, and laboratory compliance requirements.
• Experience with analytical techniques such as HPLC, GC, UV, pH, conductivity, TOC, endotoxin, bioburden, sterility, or other QC methods will be advantageous.
• Able to execute and document method validation activities according to approved protocols.
• Comfortable working with electronic systems for sample tracking, document control, training, and material/batch-related transactions.

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 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 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.