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

Recruit Express Pte Ltd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore seeks a QC lead to drive equipment qualification and method lifecycle projects in a GMP lab. You will lead qualification, validation and transfers for QC methods, while acting as SME for troubleshooting and investigations.

The role requires a Diploma in chemistry/biochemistry/biotechnology and 3+ years in GMP pharma. Strong project management and communication skills are essential, with Six Sigma exposure a plus.

Qualifications

• Diploma in Chemistry, Biochemistry, Biotechnology or related field.
• Min 3 years in pharma/biopharma GMP environment.
• Hands-on QC equipment qualification incl. protocol writing.
• Experience in method validation/transfer and data trending.

Responsibilities

• Lead analytical equipment qualification and re-qualification projects; author protocols and reports.
• Drive method validation, verification and transfer for QC methods (ICH Q2, USP).
• Act as SME for lab troubleshooting and investigations of invalid/unexpected results.
• Establish control trends and qualify reference standards, reagents and materials.
• Support regulatory submissions and QC launches with cross-site teams.
• Coordinate compendial reviews and drive method harmonisation and improvements.
• Prepare for audits and mentor junior team members.

Skills

Project management

Problem-solving

Communication

Quality mindset

Six Sigma exposure

Education

Diploma in Chemistry/Biochemistry/Biotechnology or related field

Tools

FTIR

Raman

HPLC

LabX

Job description

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 / )
• 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