Key Responsibilities
Documentation Management
- Prepare, review, issue, control, and archive all QC documents as per GMP requirements.
- Maintain laboratory records, logbooks, worksheets, registers, and analytical reports.
- Ensure proper documentation practices in compliance with cGMP, GLP, and data integrity requirements.
- Review analytical raw data for completeness, accuracy, and compliance.
Analytical Documentation
- Prepare and review:
- Method of Analysis (MOA)
- Specifications
- Standard Test Procedures (STP)
- Analytical Protocols and Reports
- Certificates of Analysis (COA)
- Ensure timely issuance and retrieval of controlled documents.
Data Review & Compliance
- Verify analytical reports, chromatograms, and laboratory records.
- Ensure all entries are complete, legible, accurate, and comply with Good Documentation Practices (GDP).
- Track and close documentation discrepancies and laboratory incidents.
Stability & Sample Documentation
- Maintain stability study records and documentation.
- Manage sample receipt, issuance, retention sample records, and destruction records.
- Ensure proper documentation of reference standards and working standards.
Change Control & Quality Systems
- Support Change Control, Deviation, OOS (Out of Specification), OOT (Out of Trend), and CAPA documentation.
- Maintain document revision history and change records.
- Assist during internal, external, customer, and regulatory audits.
Regulatory & Compliance Support
- Ensure compliance with WHO-GMP, Schedule M, USFDA, MHRA, and other applicable regulatory requirements.
- Prepare documentation required for inspections and audits.
- Maintain document retention and archival systems.
Coordination
- Coordinate with QA, Production, Warehouse, and Regulatory Affairs departments for document-related activities.
- Ensure timely circulation and retrieval of approved documents.
Required Qualification
- B. Pharm / M. Pharm / B. Sc / M. Sc (Chemistry or Life Sciences)
- Above 2 TO 3 Years Experience
Pay: ₹20,000.00 - ₹26,000.00 per month
Benefits:
- Leave encashment
- Life insurance
- Provident Fund
Work Location: In person
