Please Note: This is a 12-hours rotating shift role and based in Joo Koon Circle
Join Thermo Fisher Scientific's Quality Control team as a Microbiologist II. You will ensure cGMP and regulatory compliance while delivering analytical solutions through expertise in microbiology, method qualification/validation, and timely project completion. Responsibilities include overseeing lab activities, leading investigations, and promoting quality culture and compliance across the site.
Responsibilities:
- Perform quality control microbiological testing of raw materials, incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies.
- Perform monitoring for facility's utilities systems
- Perform method transfer/verification/validation.
- Manage the Environmental Monitoring Program of site.
- Perform Risk Assessment related to Environmental Monitoring.
- Manage daily lab operations in compliance with GMP and company standards.
- Update processes in response to new pharmacopoeia/regulatory changes.
- Lead lab investigations/deviations and ensure timely closure as per Quality System.
- Review laboratory test data for accuracy and compliance.
- Troubleshoot methods and equipment issues.
- Manage laboratory consumable inventory.
- Support equipment qualification
- Support aseptic process simulations
- Train and maintain training records for team members.
- Stay updated on international regulations (GMP, GLP, ICH, FDA, EP and pharmacopoeias).
- SME during audits/inspections.
- Support internal audits, inspections, and continuous improvement (PPI).
- Promote Quality Culture and 4i values.
- Adhere to HSE, GMP, and 5S standards.
- Carry out any other tasks required by reporting Manager
- Support shift work as needed.
Requirements
- Bachelor's degree in Microbiologist, Biochemistry, Biology, Molecular Biology or related scientific field
- Minimum 3+ years in pharmaceutical/biotech Quality Control.
- Knowledge of FDA, EMA, HSA, PIC/S, and ICH regulations.
- Strong cGMP knowledge and QC Microbiology techniques.
- Experience with method transfer and validation.
- Familiar with Risk Management and Environmental Monitoring Program
- Excellent communication skills in English.
- Ability to work both independently and collaboratively in a team environment and under regulatory scrutiny.
- Audit and inspection readiness experience.
