Responsibilities
- Manage the revision, distribution, and withdrawal of outdated quality documents, ensuring obsolete versions are properly archived or discarded.
- Control master documents including SOPs, test methods, validation protocols, batch records, and product review reports.
- Create and maintain a comprehensive master list of all controlled documents.
- Issue templates, logs, and analytical data forms as required.
- Review SOPs originating from other departments for accuracy and compliance.
- Oversee dispatch-related documentation and coordination.
- Administer the archival system for long-term document storage and retrieval.
- Manage vendor qualification documentation and related processes.
- Respond to customer inquiries related to quality documentation and compliance.
- Conduct in-process quality assurance rounds to verify adherence to quality systems.
- Prepare and review department-specific standard operating procedures.
- Process, review, and approve quality management system records such as CCFs, deviations, OOS results, CAPAs, and incidents.
- Support internal and client audits by providing documentation and clarifications.
- Review and approve analytical test records and certificates of analysis.
- Examine executed laboratory notebooks, R&D data packages, and analytical reports.
- Verify specifications and standard testing procedures for compliance and accuracy.
- Review equipment qualification documentation.
- Check and confirm the integrity and completeness of audit trails.
- Perform additional duties as assigned by the department head when applicable.
- Authorize batch release for finished products following quality review.
- Review and approve raw materials and packaging materials documentation.
Responsibilities
- Responsible for revision, issuance of revised documents and withdrawal of superseded quality documents and obsolete the superseded documents.
- Document control (Handling of master documents like standard operating procedures, specification & testing procedures, validation and qualification protocol, reports, batch manufacturing and cleaning records, annual product review reports etc.).
- Preparing master list of documents.
- Issuance of formats, registers and analytical data sheets.
- Review of standard operating procedures related to other departments.
- Handling of dispatch related activities.
- Handling of Archival System.
- Handling of Vendor Qualification.
- Handling of Customer Queries.
- IPQA rounds to ensure Quality System is followed in facility.
- Preparation & review of department SOPs.
- Login, handling/Review and approval of QMS documents (CCF, deviation, OOS, CAPA, Incident etc.).
- Supporting for all internal and Customer audits.
- Review and approval of ATR or COA.
- Review of executed Lab notebook, R&D data and Analytical Report.
- Review of Specification and Standard testing procedure.
- Review of Equipment qualification.
- Review and verification of Audit trail.
- Any other activity assigned by the Department Head (wherever applicable).
- Batch release of Finish products.
- Review and approval of Raw Material, Packing material.
