You will provide QA oversight to ensure cGMP compliance is maintained across manufacturing and Quality Control operations and manage quality-related activities including batch usage decisions, deviation management, audits, and release authorizations in line with defined QMS requirements and regulatory standards.
Key Responsibilities - QA and Quality Oversight:
- Ensure cGMP compliance in day-to-day Manufacturing and QC operations through regular interactions with QC personnel and shopfloor visits.
- Conduct checklist reviews, housekeeping checks, line clearance, process confirmations, facility walkdowns, and verify SOP compliance.
- Manage unplanned event investigations, monitor CAPA implementation, and oversee change controls to ensure testing accuracy and prevent adverse impacts on operations.
- Authorization Activities:
- Authorize QA processes such as Quality Tagouts, conditional equipment re...