Senior Manager
Sun Pharmaceutical Industries
- Dewas, Madhya Pradesh
- Permanent
- Full-time
- Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations.
- To release / reject the Batch after complete review of batch and related quality documentation.
- Conduct certification of BPR after completion of batch.
- Review and approve equipment qualification protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
- Review and approve Annual Product review reports for the products as per the schedule.
- Track to completion all deviation and investigations related to product release.
- Conduct thorough investigations into and complaints for products manufactured at the site and ensure on-time closure of complaints.
- Run reports in electronic systems to ensure that all requirements related to batch release are met.
- Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure batches are released to meet supply chain requirements.
- Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.
- Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.
- Review and approve Master Formula (Manufacturing / Packing Instruction) and SOPs.
- Review and approve process validation protocols and reports for accuracy, completeness, and traceability and well as adherence to protocol / procedures.
- Review and approve of QMS records in Trackwise system and ensure timely closure.
- To monitor timely initiation and completion of individual steps as per the work flow for all tackwise records.
- Provides appropriate training and development to support staff to meet their respective job responsibilities.
- Work in partnership with manufacturing, Engineering, and QC to increase knowledge and understanding of cGMP's and improve practices and procedures.