At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
- Monitoring and supervision of in process Quality Assurance Function of Manufacturing Block Penem
- Ensure compliance to cGMP for all operational activities.
- Sampling of rinse water, purified water, water for injection, pure steam, intermediate and finished products.
- Monitor the API/ formulated products against stipulated condition mentioned in batch production record.
- Monitoring/sampling during filling and packaging operations.
- Issuance and retrieval of logbooks.
- Conduct certification of batch production records for compliance and stage wise completion.
- Conduct line clearance, in process checks coding approvals at different stages of manufacturing and packaging.
- Beta lactam containment monitoring in Blocks.
- To assist in preparation of APR’s and annual review of product quality.
- Control sample collection, review and management of API and finished goods samples.
- Conduct calibration of IPQA laboratory instrument.
- SOP preparation/ initiation, review issuance and retrievals.
- Assist in Deviation, market complaints and investigation.
- Review and Approval of master (FO/MI and PO/PI) batch production records.
- Review and approval of equipment qualification protocols and reports.
- Review and approval of Process validation protocols and reports.
- To ensure contamination controls implemented and followed at site as per Contamination Control Strategy (CCS) and respective procedures.
- To monitor timely initiation and completion of individual’s steps as per the work flow for all track wise records.
- Review change proposals for impact on quality, stakeholder selection, classification, action required closure of actions and approval at appropriate stages.
- Review and closure of deviation, in track wise review of all investigation related to deviation, OOS, OOT and excursion in environmental monitoring and water sampling.
- Give required support during validation and qualification studies.
- Stability sample management of finished good samples.
- Handling of SAP with all required transactions.
- Completion of all assigned training in LMS.
- Archival, retrieval, storage & destruction of cGMP document.
- Training need identification for different job roles, preparation of Master training matrix, Assign training activities to job roles, maintain trainer Qualification log for the department, Track pending trainings and ensure training completion of department, Maintain manual training record and upload in LMS, Review certification of training completion of new employees.
- Conduct through investigation along with production for any complaints/ deviation/OOS/ stability failure for products manufactured at the site with appropriate root cause assessment, corrective and preventive action and logical/timely closure
