Trainee - Quality Assurance

Job Description :

• Ensure strict adherence to cGMP standards, GDP requirements, and all factory safety rules.
• Issue BMRs/BPRs/ECRs to the Production department as per established procedures.
• Handle issuance and reconciliation of product labels, hard books, controlled formats, ropes, and tech-lock seals.
• Assist in the review of vendor qualification documents, BMRs, and ECRs.
• Maintain proper filing and organization of BMRs, ECRs, Approved Vendor Lists, and other QA records.
• Manage issuance and retrieval of controlled documents to/from various departments through ENSUR or applicable document control systems.
• Carry out routine shop-floor visits to ensure compliance with quality procedures and regulatory expectations.
• Perform line clearance and area clearance activities prior to manufacturing operations.
• Verify document drop box contents and coordinate secure destruction of documents as per procedure.
• Support review and approval of executed batch records and cleaning records of SRU operations.
• Ensure timely archival of QA documents as per SOP requirements.
• Assist in collecting and compiling data required for preparation of Annual Product Quality Review (APQR).
• Support the initiation, documentation, and tracking of change controls and deviations.