Microbiologist (Sample handling/ GMP/ BioTech/ Pharma)
Duration: 12 Months Contract
Location: Tuas
Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.
Job Summary
- Supports the implementation of new analytical methods, qualification of new laboratory equipment, and/or supports the quality control aspects of clean zone qualification and production process qualification (e.g EM/water/gases sampling and testing or PPQ sampling and testing).
Responsibilities:
- Execute sampling and testing to supports the analytical methods transfer requirements or quality control requirement for incoming raw materials, drug substances and drug production.
- Review qualification documents from global C&Q and local project team. Coordinate the execution of lab equipment qualifications as Lab equipment SME.
- Establish lab equipment procedures and provide trainings to new staff.
- Establish lab equipment maintenance plan and coordinate internal or external troubleshooting.
- Leads investigations for OOSs or deviations in collaboration with subject matter experts. Identifies and analyse the root cause of non-conformance reports and initiates CAPAs (Corrective and Preventive Actions)
- Reviews relevance of pharmacopoeia revisions for the work area (e.g. specifications, test methods).
- Executes and coordinates change control procedures
- Maintain the lifecycle of quality control department documentation (e.g. SOPs, forms, logbook or datasheet)
- Performs all assigned activities while observing all internal and regulatory requirements (safety and quality)
- Participates in internal self inspection and external health authority audits
Requirements:
- Bachelor degree in chemistry, biochemistry or chemical engineering or other relevant sciences
- At least 3 years of industry experience in QC/ Analytics in pharmaceutical industry/ GMP environment
- Specific knowledge/ areas of expertise in one or more of these fields:
- chromatographic methods, in particular HPLC
- molecular biology (preferably e.g. RT-PCR, ddPCR, Dot-Blot, ideally experience working with RNA)
- electrophoretic methods
- spectrophotometric methods (e.g. UV-/VIS, Fluorescens, Endotoxin)
- physico-/ chemical methods including compendial methods (e.g. USP, Ph. Eur.), e.g. Dynamic light scattering, pH, osmolality, subvisible particles
- incoming goods testing/ raw material testing, sampling for incoming goods testing
- microbiology and/ or cell based assay
- Sense of ownership and honesty (proactive handling of errors)
Lim Pey Chyi (Apple) - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
