Production Documentation Officer

We are currently seeking a Production Documentation Officer for a leading pharmaceutical manufacturing facility in Dahej, Gujarat. In this role, you will be responsible for preparing, reviewing, and managing all production-related documents. Furthermore, you must ensure full compliance with cGMP standards. Consequently, this position is vital for facilitating smooth manufacturing operations and maintaining validation readiness across the site.

The Production Documentation Officer coordinates with various departments, including QA, QC, and Warehouse. Additionally, you will operate documentation systems such as Dynamics, DMS, and Nichelon. Therefore, we are looking for a detail-oriented professional who can manage quality events and documentation with high accuracy and precision.

Key Responsibilities

• Initiate item code creation for new materials and products while following up for necessary approvals.
• Prepare and update the Bill of Materials (BOM) for both new and existing products.
• Operate and manage specialized documentation systems including Dynamics, DMS, and Nichelon.
• Review executed BMRs, BPRs, and validation documents thoroughly before submission to the QA department.
• Report any discrepancies and initiate necessary change controls, deviations, NCRs, and incident reports.
• Follow up on and close action plans related to quality events and specific documentation requirements.
• Prepare and submit detailed investigation reports and trend analyses to the Quality Assurance team.
• Support the execution of process validation and ensure all documentation adheres to the protocol.

Requirements and Qualifications

Education and Experience

• B.Pharm, M.Pharm, B.Sc, M.Sc, or a relevant scientific degree.
• 2–4 years of experience specifically in production documentation within the pharmaceutical industry.
• Strong working knowledge of cGMP standards, documentation systems, and validation processes.

Technical Skills and Abilities

• Proficiency in operating advanced documentation management software and ERP systems.
• Excellent coordination skills to work across QA, QC, Packaging, and Warehouse departments.
• Ability to provide APQR and OPV data to QA while preparing additional documentation as needed.
• Analytical mindset capable of conducting trend analyses and preparing comprehensive investigation reports.

What We Look For

• A meticulous individual who takes full responsibility for compliance and documentation accuracy.
• A proactive communicator who can facilitate cross-departmental coordination for manufacturing operations.
• A dedicated professional who thrives in a highly regulated pharmaceutical manufacturing environment.

If you have the technical expertise to manage critical pharmaceutical documentation, we encourage you to apply for this Production Documentation Officer position today!