Officer

at  Sun Pharmaceutical Industries Ltd

TITLE: OFFICER

Date: Aug 24, 2024
Location: Toansa - Quality Assurance

Company: Sun Pharmaceutical Industries Ltd

• To review the BPRs as per checklist/SOP prior to usage decision and any discrepancy observed to be handled as per Good Documentation Practices (GDP) or Deviation Management System.
• To take usage decision of finished products, intermediates, RM, PM and Recovered Solvent batches in SAP after ensuring compliance to all requirements as per SOPs, Specifications, Customer & Regulatory Commitments, Exhibit Batch Protocol (as applicable).
• To response various marketing/regulatory/Customer query.
• To do the calibration and qualification of equipment/instruments/system e.g. Walk in chamber, Retention sample room etc. as per schedule and SOP.
• Generation of COA as per specification, Regulatory Commitments and customer requirement.
• Evaluation and initiation of CCR for retest revision.
• Initiation of Stability/holding time study Protocol and initiation of modification or discontinuation of stability/holding time protocols as per SOP.
• To provide data to DRA for regulatory filling and annual updates.
• Compilation of data for preparation of monthly reports.
• To provide sample for marketing and registration etc.as per requirements/SOP.
• To perform physical inspection of finished products incase of Repacking and Relabeling.
• To provide samples for marketing and registration etc. as per requirement/SOP.
• Maintenance and revision of CLP labels as per SOP.
• To ensure storage, retrieval and disposal of Retention Sample of Finished Product as per SOP.
• To perform annual inspection of retention samples.
• Initiation of Stability/holding time study Protocol and initiation of modification or discontinuation of stability/holding time protocols as per SOP.
• Monitoring of temperature and humidity (as applicable) for retention sample room and walk-in-chamber as per applicable SOP.
• Compilation of Data for preparation of monthly reports.
• To initiate test request form (TRF) for non-routine samples as per SOP.
• To ensure archival of reviewed and certified document is done as per SOP.
• To perform routine surveillance of GMP activities in Module/Plant as per checklist Q-368.
• To report any non-compliance w.r.t. GMP as per company policy and procedures.
• To review and certify, PCO BRCs, between Batch Cleaning BRCs and Solvent Recovery Batch Production Records.
• To perform physical inspection of Equipment/Facility/Area after PCO as per SOP.
• Archival of documents as per SOP.

Any other job responsibility assigned by reporting manger.

Please refer the Job description for details