QA Specialist I

ThermoFisher Scientific; Singapore; On-site; SGD 45,000 - 70,000; Full time

Job summary

A biotechnology firm in Singapore seeks a Quality Ops Specialist to ensure compliance with quality standards and regulatory requirements. The ideal candidate will have a Bachelor’s in Life Sciences or related fields and 1-3 years of experience in the pharmaceutical industry. Responsibilities include quality checks, procedural documentation, and problem-solving on the shop floor. The role offers a dynamic environment with a focus on safety and quality assurance.

Qualifications

• 1-3 years of relevant quality experience in pharmaceuticals preferred.
• Fresh graduates with relevant qualifications may also be considered.
• Experience in Quality Management Systems and biologics is an asset.

Responsibilities

• Follow site safety requirements and maintain safe working conditions during daily operations.
• Perform quality checks and solve problems on the shop floor.
• Write and review quality operational procedures.
• Provide QA support to manufacturing operations.
• Conduct acceptable quality checks for sterile products.
• Lead investigations of deviations and OOS to find root causes.

Skills

Knowledge of cGMP

Regulatory Compliance

GMP Quality Management Systems

Detailed thinking

Strong communication skills

Coordination abilities

Problem-solving skills

Knowledge of Quality Risk Management tools

Education

Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering

Job description

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Position Summary

Join Thermo Fisher Scientific Inc. as a Quality Ops Specialist for impactful work.

Responsibilities

• Follow site safety requirements and maintain safe working conditions during daily operations.
• Quality on the floor: shop floor QA performer and problem solver.
• Write all quality operational procedures and review SOPs from other functional teams.
• Provide QA support to manufacturing operations and coordinate routine shop floor compliance.
• 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.

Minimum Requirements/Qualifications

Education:

• Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area with equivalent experience.

Experience

• 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may also be considered.
• Experience in Quality Management Systems and biologics is an asset.

Proficiencies

• Knowledge of cGMP, Regulatory Compliance, and GMP Quality Management Systems.
• Strong detailed thinking and communication skills.
• Effective coordination and collaboration abilities.
• Proven problem-solving skills and knowledge of Quality Risk Management tools.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.