Job Responsibilities:
Experience: 58 years in QA/QC within regulated pharma/biopharma environments
Key Responsibilities:
- Manage QA/QC documentation and ensure compliance with cGMP and data integrity.
- Develop, review, and approve SOPs for QA and QC (Analytical & Microbiological).
- Coordinate with cross-functional teams and support audits (internal/external).
- Review stability protocols, method validation reports, and QC data for regulatory filings.
- Support computer system validation, equipment qualification, and change control processes.
Skills & Competencies:
- Strong knowledge of cGMP, QMS, ICH and regulatory compliance.
- Expertise in QA/QC documentation and data integrity.
- Hands-on experience with Novatek LIMS, LabWare LIMS, TrackWise, and Veeva.
Education:
Bachelor's in Biotechnology, Biochemistry, or related field (Master's preferred).
