Qualification & Validation Specialist
Job Summary
The Qualification & Validation Specialist provides quality oversight for system and process validation lifecycle activities at the Singapore Tuas manufacturing site. This role ensures that facilities, equipment, and processes comply with strict regulatory requirements and internal quality standards. The position involves collaborating with cross-functional teams to drive validation deliverables while safeguarding the quality and efficacy of medicinal products.
Responsibilities
- Provide quality oversight for validation activities.
- Prepare and review qualification documentation (IQ/OQ/PQ).
- Manage deviations, non-conformances, and change controls.
- Support internal/external audits and regulatory inspections.
- Collaborate with cross-functional teams on technical execution.
Required Skills
- 5-7 years pharmaceutical validation experience.
- Expertise in FDA, EMA, ICH, and ISPE standards.
- Proficiency in Quality Risk Management (FMEA, HACCP).
- Experience with aseptic manufacturing environments.
- Strong technical documentation and communication skills.
Job Details
Key Responsibilities:
- Quality Oversight: Provide oversight of qualification and validation tasks to ensure adherence to standards.
- Documentation: Prepare and review protocols, reports, risk assessments, and traceability matrices within defined timelines.
- Deviation Management: Document deviations, non-conformances, and corrective actions.
- Change Control: Evaluate change controls applying validation expertise to ensure ongoing compliance.
- Regulatory Compliance: Ensure activities align with FDA, EMA, and Sanofi quality requirements.
- Audit & Inspection Support: Participate in internal and external audits and health authority inspections.
- Cross-functional Collaboration: Partner with engineering, manufacturing, and quality control teams for smooth execution.
- Continuous Improvement: Identify and implement process improvements.
Qualifications & Competencies:
- Education: Bachelor's degree or higher in Science, Engineering, Pharmacy, or related discipline.
- Experience: Minimum 5-7 years in qualification and validation within pharmaceutical or biotechnology industries.
- Technical Expertise: Hands-on experience with FUE, computerized systems, manufacturing processes, and decontamination methods.
- Regulatory Knowledge: Deep understanding of FDA, EMA, ICH, ISO, ASTM, ISPE, and PDA standards.
- Risk Management: Proficient in FMEA, HACCP, and FTA tools.
- Documentation Skills: Mastery of IQ, OQ, PQ protocols and Validation Master Plans.
- Soft Skills: Excellent communication, independent initiative, and effective time management in a regulated environment.