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 Senior QC Chemist. You will ensure cGMP and regulatory compliance while delivering analytical solutions through expertise in biologics chemistry, method qualification/validation, and timely project completion. Responsibilities include overseeing lab activities, leading investigations, and promoting quality culture and compliance across the site.
Responsibilities:
- Support new equipment qualification, lab systems, and chemistry lab setup.
- Perform transfer/verification/validation of analytical methods.
- Prepare technical documentation (protocols, SOPs, reports).
- Conduct analysis of raw materials, intermediates, finished products, and stability samples under cGMP.
- Oversee sampling, testing, and release processes for process aids and packaging materials.
- Ensure timely chemistry testing (HPLC, GC, particle counting, etc.) to support production.
- 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 per Quality System.
- Review analytical data for accuracy and compliance.
- Perform equipment maintenance and calibration.
- Troubleshoot analytical methods and equipment issues.
- Manage QC chemical, reference standard, and consumable inventory.
- Train and maintain training records for team members.
- Stay updated on international regulations (GMP, GLP, ICH, pharmacopoeias).
- Act as 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.
- Support shift work as needed.
Requirements
- Bachelor's degree in Chemistry, Biochemistry, or Life Sciences.
- Minimum 5 years in pharmaceutical/biotech Quality Control.
- Knowledge of FDA, EMA, HSA, PIC/S, and ICH regulations.
- Strong cGMP knowledge and QC chemistry techniques (HPLC, UPLC, CE).
- Experience with method transfer and validation.
- Excellent communication skills in English.
- Ability to work cross-functionally and under regulatory scrutiny.
- Audit and inspection readiness experience.
