Quality Operations Specialist

1 week ago

Singapore THERMO FISHER BIOPHARMA SERVICES PTE. LTD. Full time $60,000 - $120,000 per year
Location/Division Specific Information

This position is based at our 31 Joo Koon Circle facility in Singapore , part of Thermo Fisher's Pharma Services Group . The site is equipped with innovative technology and supports high-quality pharmaceutical manufacturing and packaging operations. You will be part of a team that encourages collaboration and prioritizes ongoing learning while providing robust training opportunities for professional growth.

This role will initially follow normal working hours ( 8:00 AM - 5:15 PM ) for training, with occasional support for night testing. Once ready, the role will transition to a rotating day/night 24x5 shift pattern, depending on operational needs.

Discover Impactful Work:

Make a difference while advancing your career in a global science leader.

At Thermo Fisher Scientific, everything we do begins with our mission—to enable our customers to make the world healthier, cleaner, and safer. As a Quality Operations Specialist, you will play a key role in maintaining the integrity of our products and supporting world-class manufacturing processes that impact lives every day.

A day in the Life:
  • Follow site safety requirements and maintain safe working conditions during daily operations.
  • Serve as a Quality representative on the manufacturing floor, resolving issues and ensuring compliance in real-time.
  • Draft and review quality operational procedures and support cross-functional SOP development.
  • Coordinate compliance activities on the shop floor and proactively identify and address quality concerns.
  • Collect firsthand shop floor information and collaborate with operations teams to solve problems.
  • Perform Quality Monitoring for aseptic manufacturing steps.
  • Conduct Acceptable Quality Checks for sterile products.
  • Coordinate microbiology quality for vial reading of incubated media-filled vials.
  • Support QC area by reviewing QC documents.
  • Participate in site operational readiness programs, including self-inspection and data integrity surveillance.
  • Review and approve Master Batch Records and Master Formulation Records to ensure compliance with TFS quality standards and cGMP requirements.
  • Assist QA manager with batch disposition.
  • Review and approve validation documents, including computer system validation.
  • Maintain site readiness for GMP and client audits.
  • Lead or participate in deviation and OOS investigations to determine root causes and implement effective CAPAs.
  • Review and approve relevant procedures to ensure compliance with cGMP and TFS quality standards.
  • Support regulatory inspections and client audits to ensure effective management of QA operations areas.
  • To support shift work when required.
Keys to Success:
Education
  • Bachelor's degree in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related scientific field of study.
Experience
  • 1 to 3 years of experience in pharmaceutical or biopharmaceutical quality operations is preferred.
  • Exposure to Quality Management Systems and biologics manufacturing will be an added advantage.
Knowledge, Skills, Abilities
  • Solid understanding of cGMP and regulatory compliance standards.
  • Strong attention to detail and effective communication skills.
  • Ability to coordinate multi-functional teams and drive collaboration.
  • Analytical perspective with a proactive approach to solving quality issues.
  • Familiarity with quality risk management tools is beneficial.
Physical Requirements / Work Environment
  • May require walking, standing, and lifting small objects or tools for short durations.
  • Operation of computers and other equipment is required for brief periods.
  • Work is performed in a cleanroom environment; cleanroom attire (e.g., gown, gloves, mask) is required at all times.

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