Total 1,422 quality control engineer job vacancies in Quality Assurance / Control category in The Philippines

Senior Quality Validation Specialist
(6 month contract)

About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission

The essential functions include but are not limited to:

• The incumbent will be part of Digital & Data Quality (DDQ) team for Operational Support, Lifecycle Management (LCM), and Capital projects, collectively known as Projects thereafter, will be responsible for the quality aspects of Good Manufacturing Practice (GMP) computerized systems/equipment and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
• This includes involvement in all quality-related activities for computerized systems which are required by the client Manufacturing site Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• The incumbent must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Primary Responsibilities:

As part of the DDQ team and reporting to the Associate Director of DDQ or higher, the incumbent will be responsible for:

• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes. This includes:
• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Interfacing with the Manufacturing site DMO (Digital Manufacturing Organization) and other internal & external entities to align GMP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives
• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
• Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.

Requirements:

• Diploma or bachelor’s degree in chemical engineering or any other relevant engineering field
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations in GMP environment.
• At least 5 years of experience in regulated pharmaceutical manufacturing industry.
• At least 3 years of experience in delivering validated Lab Systems Qualification experiences solutions or an application support role in a regulated environment.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.

Reg No: R22104540
EA License no: 94C3609

Overview

• To promote an effective quality programme including identifying, coordinating and participating with relevant departments on quality and patient safety training needs, standards development, design and implementation of audit tools and risk management activities:
• Keep abreast of appropriate regulatory agency requirements related to quality assurance, patient safety standards and other relevant regulatory requirements (e.g., Personal Data Protection Act and Health Information Bill/ Act);
• To initiate continuous service improvements through constant monitoring, audits and training.

Responsibilities

• Manage incidents, customer feedback/ complaints and provide timely responses and effective preventive measures
• Identify and develop strategies to mitigate risks, improve clinical quality and patient safety. Measure and evaluate data to determine the ultimate impact of the programs and initiatives
• Work with consultants and internal customers to achieve and maintain certifications
• Operationalization of Health Information Bill/ Health Information Act
• Collaborate with cross-functional teams to analyze and optimize healthcare processes, workflows, and procedures
• Maintain statistics on Quality Indicators e.g., Productivity, Customer Service Survey Data (including incidents, feedback, compliments, complaints). Prepare documents for management reporting as required
• Assist to develop, implement and review policies and procedures relating to quality management functions for standardisation and compliance to quality and regulatory standard
• Maintain an inventory of all documents within the organisation as document controller
• Maintain external correspondences including MOH/ AIC/ MOM, ensure all correspondences are tracked
• Identify and assess potential risks to patient safety and quality of care
• Any other tasks as assigned by the Manager/ CEO

Interested candidates, please forward your resume to kevynhuang@recruitexpress.com.sg

Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)

Job Description

• Industry/ Organization Type: Chemical Manufacturing
• Position Title: QA Engineer
• Working Location: Tuas (Walk distance from MRT)
• Working Hours: 5 Days, Monday – Friday (8.30am – 5.30pm)
• Salary Package: Basic Salary + Allowances + AWS + VB
• Duration: Permanent

Key Responsibilities

• Manage incoming inspections and evaluate supplier performance, identifying trends and implementing quality improvements.
• Track product quality from incoming to outgoing stages using SPC, ensuring compliance with customer specifications.
• Maintain and update QA documentation in line with ISO standards and internal quality systems.
• Work closely with cross-functional teams to resolve quality-related issues across departments.
• Ensure the accuracy and integrity of QA data and records according to established procedures.
• Investigate quality issues, perform root cause analysis, and implement corrective actions.
• Support customer queries by preparing and coordinating quality-related documentation.
• Prepare and review quality documents (e.g. COA, reports) in accordance with procedures and customer requirements.
• Handle customer complaints by conducting investigations and ensuring timely resolution with proper documentation.
• Coordinate sample evaluations and ad-hoc sampling activities, analysing data to support quality decisions.
• Plan and participate in internal and external audits to ensure compliance and audit readiness.
• Conduct risk assessments, FMEA, and training, while supporting continuous improvement initiatives.
• Promote and participate in company quality and EHS programmes.
• Carry out additional duties as assigned in line with business needs.

APPLY NOW!!!

• Diploma or Degree in Chemical, Science, or a related discipline.
• Minimum 2-3 years of relevant experience.
• Solid knowledge of quality control practices and statistical analysis techniques.
• Effective communication skills, both written and verbal, with good interpersonal and presentation abilities.
• Familiarity with ISO9001, ISO14001, and ISO45001 standards will be an added advantage.
• Proficient in Microsoft Office applications.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job@anradus.com.sg. Please indicate #83859 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Rachael Lee | EA Reg No.: R2093131

• Ensure all quality control documentation is compiled and completed for as-built handover through the QC turnover engineer
• Review and prepare reports on Authority inspections (RI inspection, BCA TOP inspection, etc)
• Establish Project Quality System, implement and maintain in accordance with Singapore standards application to BCA for CONQUAS Assessment and provide a framework to achieve the score
• Assess the implementation of the Quality Plan and Quality Control Plans on site
• Ensure the project QA/QC plan follows specifications and contract requirements
• Compete for site quality control instructions and action remedial responses
• Coordinate quality inspections with all the site subcontractors and vendors and coordinate all non-destructive testing on site
• Distribute relevant QA/QC documentation to site subcontractors
• Verify the quality-related site activities are in accordance with the applicable codes and standards
• Participate in the site's internal and external site audits
• Coordinate all the quality site inspections through the site QC inspectors
• Control all nonconformance reports and undertake remedial action
• Must have fluent English communication skills to liaise with the Client’s staff
• Have Main Contractor Experience

1. Job Purpose:

The Internal Control Manager is responsible for designing, implementing, monitoring, and improving the company’s internal control framework to ensure compliance with regulatory requirements, strengthen risk management, and support operational effectiveness. The role ensures the company meets all obligations under relevant listing rules, corporate governance codes, and internal control standards. The role is also responsible for consolidated management accounts, budget preparation, reliable financial forecasting, and quarterly and annual statutory reporting.

1. Main Responsibilities:

2.1 Internal Control Framework & Governance

• Develop and maintain an enterprise-wide internal control framework aligned with COSO and regulatory expectations.
• Evaluate and improve the effectiveness of internal controls over financial reporting (ICFR), operations, and compliance.
• Lead periodic assessments of control adequacy, control self-assessment (CSA) programs, and risk/control matrices.

2.2 Regulatory Compliance (Listed Company Requirements)

• Ensure compliance with stock exchange regulations (e.g., SET/SEC Thailand or other listing rules).
• Support preparation and certification of internal control declarations for annual reporting.
• Coordinate with regulators, auditors, and stakeholders on internal control matters.
• Monitor changes in regulatory requirements and update internal control practices accordingly.

2.3 Risk Management Integration

• Work with the Risk Management team to align internal controls with key risks identified in the enterprise risk assessment.
• Conduct risk‑based reviews to identify weaknesses, control gaps, and process inefficiencies.
• Recommend and oversee remediation plans.

2.4 Process Improvement & Efficiency

• Review business processes to identify opportunities for automation, standardization, and efficiency.
• Lead cross-functional initiatives to strengthen governance, reduce control failures, and enhance operational effectiveness.
• Partner with IT to assess and strengthen IT general controls (ITGC) and application-level controls.

2.5 Audit Coordination

• Serve as the primary liaison for internal and external audits.
• Coordinate audit schedules, documentation requests, and management responses.
• Track audit findings and ensure timely implementation of corrective actions.

2.6 Policy & Procedure Management

• Develop, update, and communicate internal policies, procedures, and control guidelines.
• Conduct periodic reviews to ensure policies are aligned with best practices and regulatory standards.
• Provide training and support to employees to reinforce control awareness.

2.7 Management Reporting

• Prepare internal control dashboards, risk/control matrices, and periodic reports for management, Audit Committee, and Board of Directors.
• Present findings, gaps, and improvement strategies to senior leadership.
• Provide insights on control weaknesses and recommend practical solutions.

2.8 Review of Consolidated Financial Statements

• Review monthly and quarterly consolidated financial statements prepared by the Global Shared Service Center (GSSC) and local accounting teams to ensure accuracy and compliance with international accounting standards.
• Validate reporting from international subsidiaries and hub entities, ensuring alignment with corporate requirements.
• Identify discrepancies, recommend adjustments, and ensure financial data is properly reflected in reports.

2.9. Ad-hoc Financial Support & Special Projects

• Perform additional financial analysis and reporting as assigned.
• Support special projects relating to international hubs, including mergers & acquisitions, due diligence, system implementations, and process improvements.