8 - 13 years
7 - 12 Lacs
Vapi
Posted:23 hours ago|
Platform:
Work from Office
Full Time
Role & responsibilities Manage and oversee work orders for syringe processing lines, ensuring efficient execution of production plans to maximize machine performance. Plan and implement batch production on a product-specific basis, optimizing throughput and minimizing downtime. Collaborate with cross-functional departments to ensure uninterrupted operations and timely execution of preventive maintenance schedules. Lead initiatives to reduce market complaints, aiming to maintain a production ratio of over 20 million units per justified complaint. Review BMR for new products to be processed on syringe lines. Review and approve BMRs for new products prior to processing and verify completed BMRs for submission to Quality Assurance. Develop, review, and implement SOPs for syringe processing operations, ensuring thorough training and compliance among line operators. Monitor and enhance line yield while working to minimize rejection rates through process improvements and quality control measures. Ensure timely preparation of customer samples as per specifications, with accurate documentation in BMRs and logbooks. Oversee SAP activities related to batch processing, including data entry, reconciliation, and return of unused materials to inventory.. Ensure optimal shift-wise performance of SPRC machines, maintaining complete and accurate documentation in SAP, BMRs, and logbooks. Prioritize and coordinate the ETO process of completed batches, ensuring all related entries are updated in both BMRs and SAP. Maintain audit readiness by ensuring no critical observations in the production area through strict compliance and monitoring. Ensure NVPC records are correctly attached to the respective BMRs and submitted to QA within the designated timeline. Lead training programs for staff and operators on cleanroom protocols and enforce adherence to cGMP standards. Ensure full compliance with the most recent EHS guidelines across all production activities. Drive continuous improvement of the EHS management system through effective implementation, monitoring, and periodic review. Preferred candidate profile Education Qualification Mpharm /Bpharm /BSc /Msc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited institution. Experience Experience: 8-12 years of experience in sterile injectable/aseptic pharmaceutical manufacturing (preferably in processing functions).
Randstad
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