QC Principal Scientist (Metrology)

About the role

This role covers the metrology and computer system qualification of QC instruments within a pharmaceutical QC lab. It spans the startup phase of the lab and the routine GMP phase, acting as the on-site subject matter expert for metrology and computer system qualification.

Key responsibilities

• Support the setup of QC instruments and computer systems: user configuration, system testing and SOP generation with the OPS/Metrology lead.
• Plan the instrument and equipment qualification strategy with the OPS/Metrology lead.
• Implement and continuously improve QC metrology and computer system qualification processes.
• Act as on-site SME for root cause analysis and CAPA, and give input on data review and investigations; lead client discussions on project quality and investigations.
• Evaluate technical data accurately and legibly, and coordinate with QA on data integrity compliance.
• Prepare SOPs, protocols, final reports, investigations and deviations, and train staff on instrument technical expertise and compliance.
• Review equipment calibration and maintenance reports, maintain laboratory notebooks and worksheets, and align SOPs with global corporate standards.

Required profile

• Diploma, Bachelor's degree or above in Chemistry, Microbiology, Biochemistry or a related scientific discipline.
• 5 to 10 years of experience in quality control, quality assurance, auditing, compliance or a related GMP-regulated environment.
• Strong written and verbal communication, interpersonal and scientific writing skills.
• Intermediate to advanced Microsoft Word, Excel and PowerPoint.
• Familiarity with computerized system regulations such as CFR 21 Part 11 and EU GMP Annex 11.
• Experience with instrument qualification, calibration, preventive maintenance and repair (UPLC, HPLC, CE, CIEF).
• A plus: instrument operation and sample testing, handling deviations and change control, and using software such as Empower, SoftMax Pro, EndoScan-V, Lab-X and LIMS.