Senior Officer - Production Documentation Cell

About the Role

Sun Pharma invites applications for the position of Senior Officer in the Production Documentation Cell at its Toansa site. The company fosters an environment where employees are encouraged to grow, take ownership of their career, and succeed together as a team.

Key Responsibilities

• Initiate, review, and obtain QA approval for change controls related to processes, equipment, and facilities using the TrackWise system to meet production needs across all modules at Toansa.
• Prepare initial drafts of Manufacturing Procedure Records (MPRs) and Batch Record Cards (BRCs) with relevant data according to module-specific production requirements.
• Upload draft MPRs/BRCs into the BPR Printing Module for subsequent execution and release.
• Develop, review, and secure QA approval for various validation and qualification documents, including protocols, reports, PPV, SPR, temperature mapping, product manuals, plant development reports, cleaning matrices, CPDR, equipment suitability assessments, HAZOP studies, and investigations related to OOS/OOT/UPD, adhering to current SOPs.
• Coordinate collaboratively with production teams to gather necessary data and documentation for CCR, validation, and qualification activities to ensure complete records.
• Monitor the progress of CCRs and protocol activities against due dates, providing justified extensions in TrackWise when required.
• Prioritize CCR, validation, and qualification documentation efforts to align with production schedules.
• Standardize documentation practices associated with CCRs, validation, and qualification across the site.
• Ensure high-quality documentation conforming to Good Documentation Practices (GDP) to minimize review/approval lead times and maintain productivity.
• Report any delays or obstacles in completing documentation to relevant managers and team leaders promptly.
• Uphold company values consistently in all work aspects.
• Adhere strictly to cGMP, SOPs, and safety measures relevant to the role.
• Follow schedules carefully to prevent deviations and ensure compliance.
• Complete all assigned trainings timely through the Learning Management System (LMS).
• Lead and manage all training activities within the Document Cell, including assigning trainings to job roles, reviewing completion of job-specific trainings, organizing training sessions, and maintaining training attendance and records.
• Continuously track and follow up on pending trainings to ensure timely completion.

Qualifications and Experience

• Master's degree in Chemistry (M.Sc.).
• Relevant experience of 5 to 8 years working in an API manufacturing plant.
• Strong knowledge of current Good Manufacturing Practices (cGMP), U.S. Food and Drug Administration (FDA) regulations, and industry best practices.

Additional Information

This role is based onsite at the Toansa facility of Sun Pharma. The role may require coordination and travel for various activities. Sun Pharma values employee success and wellbeing, offering comprehensive benefits and opportunities for personal and professional development. The job description is intended to outline general responsibilities and qualifications and may be adjusted according to organizational needs.