Senior Quality Operations Specialist (12 hours Rotating Shift)

THERMO FISHER BIOPHARMA SERVICES PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A global leader in scientific services is seeking a Senior Quality Operation Specialist in Singapore. This role involves ensuring GMP compliance, supervising quality operations on the shop floor, and conducting quality monitoring for aseptic manufacturing processes. Applicants should have a Bachelor’s degree in a relevant scientific area and 4-6 years of experience in quality within the pharmaceutical or biopharmaceutical sectors. Strong problem-solving skills and a keen analytical mindset are essential for success in this role.

Qualifications

• Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area.
• 4-6 years of relevant Quality experience in Pharmaceuticals/Biopharmaceuticals is required.

Responsibilities

• Ensure compliance with GMP requirements.
• Perform Quality Monitoring for aseptic manufacturing processes.
• Lead root cause analysis with effective CAPA.

Skills

Quality Monitoring

Problem-solving

Analytical skills

Communication

Root Cause Analysis

Education

Bachelor’s Degree in Life Sciences or related field

Job description

Position Summary

At Thermo Fisher Scientific Inc., we offer an outstanding opportunity for a Senior Quality Operation Specialist to join our dedicated team. In this meaningful role, you will be responsible for accomplishing quality operational and compliance activities to maintain GMP compliance across our shop floor, engineering, and warehouse. Under the vigilant mentorship of our QA Manager, you will ensure site adherence to GMP requirements and corporate policies, driving continuous improvements in our quality system. You’ll play a significant role in identifying near misses in the manufacturing area, safeguarding product quality, and ensuring patient safety.

Responsibilities

• Follow site safety requirements and maintain a safe working condition during daily operations.
• Provide shop floor QA supervision and problem-solving support to manufacturing operations, ensuring routine compliance.
• Perform Quality Monitoring for aseptic manufacturing processes and Acceptable Quality Checks for sterile products.
• Coordinate quality in microbiology, including vial reading for incubated media-filled vials.
• Support QC area by reviewing QC documents and participating in operational readiness programs.
• Assist QA manager with batch disposition and review validation documents, including computer system validation.
• Assess incoming materials for new product introductions and write operational procedures, reviewing all SOPs.
• Collect and analyze shop floor information, working with operations to resolve issues as a QA representative.
• Review and approve Master Batch Records and Master Formulation Records, ensuring compliance with TFS standards and cGMP requirements.
• Ensure all-time readiness for GMP and client audits, participating in deviation and OOS investigations.
• Lead root cause analysis with effective CAPA and support process validation, clean validation review, and approval.
• Establish and improve QA Operations procedures to enhance quality and efficiency continuously.
• Ensure all time readiness of the site for regulatory audit.
• Support the site Regulatory Inspections and client audit to assure that QA Operations related areas of each inspection are being accurately and efficiently handled.
• Involved in deviation and OOS investigation as quality representative:
• Participate in site operational readiness programmes like self-inspection, data integrity surveillance, fit and finish program.
• Review and approve Master Batch record and master formulation record in a timely manner to ensure MBR and MFR meet TFS quality standard and cGMP requirements.

EHS

• Implement emergency procedures and safe systems of work compliance.
• Adhere to environment, health, and safety rules, reporting and investigating all accidents, near misses, and rule breaches promptly.

Minimum Requirements/Qualifications

Education:

• Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area.

Experience:

• 4-6 years of relevant Quality experience in Pharmaceuticals/Biopharmaceuticals is required.
• Experience in Quality Management Systems, quality operations, and biologics/aseptic training is an asset.