Key Production Leadership Role for Biocon
4 weeks ago
Biocon seeks a skilled and experienced Production Manager to lead our injectable production facility.
Role OverviewThe successful candidate will be responsible for handling filling lines, lyophilizers, compounding, filtration, and packing activities. They will also oversee aseptic operations, regulatory audits, and equipment qualification.
Key Responsibilities- Manage filling lines with isolator - Vial, Prefilled syringe & Cartridge including visual inspection and packing lines.
- Handle Lyophilizer with Automatic loading and unloading system.
- Oversee Compounding, filtration, filling, and packing activities.
- Ensure Aseptic operation and training requirement of employees.
- Handle injectable regulatory audits and maintain facility readiness.
- Qualify all equipment's, facility, media fills, and batches execution.
- Manage Pen devices - assembling and packing.
- Setup the injectable facility w.r.t Equipment's, instruments, process meeting the product and regulatory requirement.
- Ensure procurement of all the material required for production on time for start-up till execution of media fills and batches.
- Use Quality& operational Tools - DMS, Track wise, VLMS, MES - paperless system.
- Responsible for Preparation & Review of URS, Risk assessments, technical rationale documents for all the Equipment's and instruments - injectable facility.
- Prepare, review, and approve Process and Packaging Validation protocol or report.
- Initiate and work upon Operational Excellence projects.
To succeed in this role, you will need:
- B Pharm / M Pharm Qualification.
- 12Yrs to 15 Yrs experience in pharmaceutical manufacturing.
This position offers a competitive salary range of $120,000 - $180,000 per annum, depending on qualifications and experience. Additionally, we provide opportunities for career growth and professional development.
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