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 Valuable 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