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

Perks

- Leave encashment

- Life insurance

- Provident Fund

Work Location: In person

📌 QC Officer Documentation (Ranu)
🏢 RENOWN PHARMACEUTICALS
📍 Ranu