Downstream Operations Leader
Symbiotec Pharmalab Pvt. Ltd.Indore, Republic Of India, IN16 days ago
Job descriptionEnsure cGMP , FDA , WHO , and other regulatory compliance in downstream operations. Review and approve Batch Manufacturing Records (BMRs) , SOPs , and Change Controls related to downstream processes. Lead and support regulatory audits (USFDA, EU, TGA, etc.) and internal quality inspections. Manage and mentor a team of shift managers, supervisors, operators , and technical staff. Conduct performance reviews , skill development , and ensure a culture of safety and accountability . Collaborate with Process Engineering, R&D, and QA to implement process optimizations and technology upgrades . Drive initiatives such as QbD, PAT , and Lean Manufacturing in downstream operations. Coordinate with SCM to ensure availability of consumables and utilities for uninterrupted operations. Monitor and control production costs , material losses , and energy consumption .
Key Responsibilities :
Operational Leadership :
- Lead and oversee all downstream API production activities including filtration, centrifugation, drying, milling, sifting, and packing .
- Ensure adherence to production targets , quality standards , and delivery timelines .
- Drive continuous improvement in yield, throughput, and efficiency while minimizing waste and downtime.
Compliance & Documentation :
Team Management :
Process Improvement & Technology :
Inventory & Cost Control :
Experience Required :
15+ Years in API Manufacturing.
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Operation • Indore, Republic Of India, IN
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