The posting
Join a biologics pharmaceutical MNC producing therapies for rare diseases, and take the lead on QC equipment qualification and method lifecycle projects in a GMP lab.
What You'll Be Doing
- Lead analytical equipment qualification and re-qualification projects, including authoring qualification protocols and reports
- Drive method validation, verification and transfer for new and remediated QC methods (ICH Q2, USP <1225>/<1226>)
- Act as subject matter expert for lab troubleshooting, invalid results and unexpected results investigations
- Establish control trends and qualify reference standards, reagents and critical materials
- Support regulatory submissions and QC method launches with cross-site and cross-functional teams
- Coordinate compendial reviews and drive continuous improvement and method harmonisation
- Prepare for and present at audits; coach and mentor junior team members
What You'll Bring
- Diploma in Chemistry, Biochemistry, Biotechnology or related field and above
- At least 3 years of experience in a pharmaceutical, biopharmaceutical or related GMP manufacturing environment
- Hands-on experience in QC equipment qualification, including protocol writing (e.g. FTIR, Raman, HPLC, LabX)
- Experience in method validation/transfer, control trending and critical material qualification
- Good knowledge of cGMP and regulatory requirements for equipment qualification
- Strong project management, problem-solving and communication skills; Six Sigma / DMAIC exposure is a plus
What's In It For You
- 5-day work week, office hours with an early start and early finish
- Accessible location near MRT
- High-impact role in a global biologics organisation
Interested? Click Apply or send your updated CV to [email protected]
Leon Leong De Cong R1551708 Recruit Express Pte Ltd EA License No. 99C4599



