Quality Operations Specialist
Thermo Fisher Scientific · Singapore
QualityFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Quality Operations Specialist to ensure manufacturing compliance with GMP and regulatory standards. The role involves quality monitoring, batch record reviews, investigations, and continuous improvement across pharmaceutical operations in Singapore on a 12-hour shift schedule.
What they're looking for
- Bachelor's degree in Life Sciences, Chemical/Biochemical Engineering, or Pharma-related field
- 4–6 years of quality experience in pharmaceutical or biopharmaceutical manufacturing
- Knowledge of Quality Management Systems and quality operations
- Experience with aseptic and biologics manufacturing processes
- Familiarity with GMP compliance and regulatory audit requirements
What you'll be doing
- Oversee shop floor quality assurance operations and support manufacturing compliance with safety standards
- Monitor aseptic manufacturing processes and perform quality checks on sterile products
- Review, approve, and maintain Master Batch Records and Master Formulation Records per cGMP requirements
- Lead deviation and out-of-specification investigations, root cause analysis, and corrective action planning
- Prepare and support regulatory and client audits, ensuring site readiness and audit documentation completeness
Privacy & handoff
This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.