Posted:3 hours ago|
Platform:
Work from Office
Full Time
1. Documentation Issuance & Control
- Issue Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks to production as per SOP. - Maintain master documents for BMR, BPR, SOPs, and other controlled documents with proper version control. - Implement and maintain document control systems as per GDP and cGMP requirements.
2. Batch Record Review & Compliance
- Review executed BMR and BPR for completeness, accuracy, and compliance with approved specifications. - Coordinate with production to resolve discrepancies, deviations, and documentation errors.
3. SOP & Change Control
- Assist in preparation, review, and revision of SOPs related to QA and documentation practices. - Support change control, deviation, and CAPA processes related to documentation.
4. Audit & Regulatory Support
- Ensure readiness for internal and external audits by maintaining accurate documentation. - Provide necessary documents and records during inspections (USFDA, WHO, MHRA, etc.).
5. Training & Coordination
- Train production and QA staff on Good Documentation Practices (GDP) and documentation SOPs. - Coordinate with other departments for timely closure of documentation requirements.
6. Data Integrity & Archiving
- Ensure compliance with data integrity principles in all document handling activities. - Maintain systematic archival of controlled documents for easy retrieval and regulatory compliance.
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