QA Operations Manager

2 weeks ago


Singapore PATHNOVA LABORATORIES PTE. LTD. Full time

The QA Operations Manager will be part of a team that is currently established to setup the Quality Operations processes for a brand-new mammalian cell culture facility.

He/ She specifies quality requirements for manufacturing processes and ensures that manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality and Compliance representative he/she will be a key member in cross-functional team driving measures for product safety, product quality & cGMP compliance are implemented.

Key responsibilities:

- Owns all quality related responsibilities for the biomanufacturing processes
- Represents QA in project and technology transfer within organization
- Responsible for review and final release of key QMS records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required
- Ensures all deviations are appropriately investigated and recorded, directs the investigations of customer product complaints and assures the completion of the appropriate documentation
- Identifies emerging QA relevant topics, and works actively on their development into new or already established Quality and Compliance strategies and/or standards

Key requirements:

- Bachelor, Master, Engineering degree in biomedical, biotechnology, life science or related fields
- Sound experience in the cGMP regulated environment with a min 5 years’ in QA/QC sterile processing and/or microbial experience of similar capacity.
- Strong knowledge of management of quality system (ISO13485, ISO13408, 21 CFR part 820).
- Strong experience in the area of process improvement and technical operations
- Great knowledge of biologics/biotech manufacturing processes and analytical methods
- Ability to oversee project execution to identify non-compliance from quality standards
- Experience in cell culture, cell or gene therapy experience is a plus.



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