Pharmaceutical | Biotechnology | Medical Device and In-Vitro Diagnostics
- Assisted in qualification of pilot plant facility
- Conducted training sessions in GLP and GMP practices for R&D personnel
- Implemented quality systems for start-up company
- Performed internal and external audits for cGMP compliance
- Provided manufacturing support for clinical production
- Served in QA and manufacturing management roles
- Validated laboratory equipment for analytical testing
- Investigated and resolved non-conformances and implemented CAPAs
- Assisted with resolving outstanding customer complaints
- Set up QA department, prepared SOPs, and managed audit program
- Set up environmental monitoring program and developed supporting SOPs
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