Lead Injectable Production Manager
3 days ago
We are seeking a highly experienced and skilled Lead Injectable Production Manager to join our team at Biocon. The ideal candidate will have a strong background in pharmaceutical manufacturing, particularly in injectable production, with a proven track record of leading cross-functional teams to achieve production goals.
Key Responsibilities:- Oversee the filling lines with isolator for vial, prefilled syringe & cartridge, including visual inspection and packing lines.
- Handle lyophilizer operations with automatic loading and unloading systems.
- Manage compounding, filtration, filling, and packing activities.
- Ensure aseptic operations and provide training to employees.
- Conduct regulatory audits and maintain facility readiness.
- Qualify all equipment, facilities, media fills, and batches.
- Assemble and pack pen devices.
- Set up injectable facilities, meeting product and regulatory requirements.
- Procure materials on time for start-up, media fills, and batch execution.
- Manage quality and operational tools, such as DMS, TrackWise, VLMS, and MES.
- Prepare and review URS, risk assessments, technical rationale documents.
- Develop process and packaging validation protocols or reports.
- Implement Operational Excellence projects.
- Maintain compliance with documents and practices.
- C coordinate SAP procurement for operations.
- Complete new project timelines.
- Prepare, review, and approve SOPs, protocols, batch records, and QMS documents.
- Foster safety, health, and environmental norms.
- Achieve production targets with quality, cost, and efficiency standards.
- Optimize production processes for injectables.
- Develop opex and capex requirements.
- Ensure area and equipment readiness.
- Address and resolve production issues promptly.
- Facilitate effective communication within the team and other departments.
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Senior Production Lead
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Key Production Leadership Role for Biocon
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Production Director
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Pharmaceutical Production Leader
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