Key Responsibilities
Startup Phase:
Participate in the start-up operations of the SG QC lab operations needs in terms of departmental goals and objectives:
- Instrument/Equipment & Computer System Setup - Support user configuration, system testing, and SOP generation for QC instruments with OPS/Metrology lead.
- Instrument/Equipment Qualification Strategy - Plan and strategize Instrument/Equipment qualification strategy with OPS/Metrology Lead.
Routine GMP Phase:
- Responsible for the implementation and continual improvement of the QC metrology qualification/computer system qualification processes.
- Act as on-site SME for metrology or computer system qualification root cause analysis or CAPA.
- Provides key input and recommendation of data review or investigation process. Serves as lead for client discussions regarding project quality or investigations related to studies.
- Proficient in microbiological, protein-based assays, including bioburden, endotoxin, HPLC, CE electrophoresis, ELISA, PCR and/or potency analytical methods.
- Use proficiently advanced laboratory equipment, such as, but not limited to HPLC, CE, PCR, plate readers, etc.
- Effective multi-tasking skills and time management required.
- Able to evaluate technical data and record data accurately and legibly.
- Able to work with QA in coordination towards adhering and supporting Data Integrity compliance towards work and review
- Provide training in the areas of technical expertise and compliance issues relevant to the analytical instrument.
- Prepare SOP, protocols, final reports, investigations, and deviations as needed.
- Conduct timely review of equipment calibration/maintenance reports and data appropriately.
- Maintain/review laboratory notebooks and worksheets for QC equipment/software as required
- Able to develop/align QC equipment and software systems laboratory SOPs with global corporate standards.
- Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Any other tasks or projects deemed necessary by the superior to support the QC department.
Requirement :
- Diploma / Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.
- 5 - 10 years of relevant experience in quality control, quality assurance, auditing, compliance or a related GMP‑regulated environment, with depth and breadth appropriate to the role.
- Strong communication skills, both written and verbal, and outstanding interpersonal skills.
- Strong skills in scientific and technical writing.
- Good software operation skills, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
- Critical thinking, scientific reasoning and problem-solving skills.
- Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc.
- Familiar with analytical instrument/equipment qualification, calibration, PM and repair, such as UPLC, HPLC, CE and CIEF etc.
Would be a plus if having the following working experiences:
- Analytical instrument/equipment operation and sample testing.
- Handling deviations, change control, and responding to audit questions.
- Operation of instrument software, including but not limited to LES, ELN, Cispro, Empower, SoftMax Pro,, EndoScan-V, Lab-X., and LIMS for Lab Admin role.