QC Documentation Officer

Renown Pharmaceuticals; Vadodara; Sur place; INR 400 000 - 650 000; Plein temps

Résumé du poste

Renown Pharmaceuticals seeks a detail-oriented QC Documentation Officer to manage all QC documentation in line with cGMP, GLP and data integrity requirements. You will prepare, review, issue and archive QC documents, review analytical data and support quality systems and regulatory audits.

The role includes maintaining stability and sample documentation, supporting change control processes, and coordinating with QA, Production and Regulatory Affairs to ensure compliant documentation across the

Qualifications

• B.Pharm, M.Pharm, B.Sc or M.Sc in Chemistry or Life Sciences required.
• 2–3 years of hands-on QC documentation or QC/QA experience in pharma manufacturing.

Responsabilités

• Prepare, review, issue, control and archive QC documents per GMP.
• Maintain lab records, logbooks, worksheets, registers and reports.
• Ensure GDP and data integrity; review analytical data and audit trails.
• Support change control, deviations, OOS/OOT and CAPA documentation.
• Assist during audits and regulatory inspections.

Connaissances

Attention to detail

Documentation control

GDP ALCOA+

Formation

B.Pharm/M.Pharm/B.Sc/M.Sc (Chemistry or Life Sciences)

Description du poste

Department: Quality Control

Job Summary

We are looking for a detail-oriented QC Documentation Officer to manage all Quality Control documentation in line with cGMP, GLP and data integrity requirements. The role covers preparing, reviewing, issuing and archiving QC documents, reviewing analytical data, and supporting quality systems and regulatory audits.

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 documentation practices comply with cGMP, GLP and data integrity (ALCOA+) principles.
• Review analytical raw data for completeness, accuracy and compliance.

Analytical Documentation

• Prepare and review Methods of Analysis (MOA), Specifications, Standard Test Procedures (STP), Analytical Protocols and Reports, and Certificates of Analysis (COA).
• Ensure timely issuance and retrieval of controlled documents.

Data Review and Compliance

• Verify analytical reports, chromatograms and laboratory records.
• Ensure all entries are complete, legible and accurate, and follow Good Documentation Practices (GDP).
• Track and close documentation discrepancies and laboratory incidents.

Stability and Sample Documentation

• Maintain stability study records and documentation.
• Manage sample receipt, issuance, retention sample and destruction records.
• Maintain proper documentation of reference standards and working standards.

Change Control and 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 and Compliance Support

• Ensure compliance with WHO-GMP, Schedule M, USFDA, MHRA and other applicable regulations.
• Prepare documentation required for inspections and audits.
• Maintain document retention and archival systems.

Coordination

• Coordinate with QA, Production, Warehouse and Regulatory Affairs for document-related activities.
• Ensure timely circulation and retrieval of approved documents.

Required Qualification and Experience

• B.Pharm M.Pharm B.Sc M.Sc (Chemistry or Life Sciences)
• 2 to 3 years of relevant experience in QC documentation or a QC/QA role in a pharmaceutical manufacturing environment

Key Skills

Technical Skills

• Strong knowledge of cGMP, GLP, GDP and data integrity (ALCOA+)
• Preparation of MOA, STP, specifications, protocols and COA
• Review of analytical raw data, chromatograms and audit trails
• Handling of stability studies, reference/working standards and retention samples
• Working knowledge of Change Control, Deviation, OOS, OOT and CAPA
• Familiarity with WHO-GMP, Schedule M, USFDA and MHRA guidelines
• Document control, version management and archival systems
• Basic understanding of analytical instruments (HPLC, GC, UV, etc.) and their documentation

Soft Skills

• Strong attention to detail and accuracy
• Good written and verbal communication
• Time management and ability to meet deadlines
• Cross-functional coordination and teamwork
• Integrity, accountability and a compliance-first mindset

Computer Skills

• Proficiency in MS Word, Excel and PowerPoint
• Familiarity with QMS, LIMS or electronic document management systems (preferred)

Preferred Candidate Profile

• Has 2 to 3 years of hands-on experience in QC documentation in a pharmaceutical formulation or API unit
• Has been through regulatory or customer audits (WHO-GMP, USFDA, MHRA) and supported audit readiness
• Is comfortable reviewing raw data and spotting documentation gaps or data integrity issues
• Has experience closing deviations, OOS/OOT investigations and CAPA records
• Is organized, methodical and able to manage multiple documents and deadlines
• Is willing to work in a regulated, audit-driven environment
• Candidates from the Vadodara/Gujarat region or willing to relocate will be preferred
• Immediate or short-notice joiners preferred