QC Specialist (Equipment Qualification, Biologics Pharma, Office Hours) #HDC1

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