Purpose To ensure the smooth and compliant transfer of pharmaceutical formulations from R&D; to manufacturing, ensuring scalability, consistency, and regulatory compliance for successful product commercialization.
Position / Job Title
Assistant Manager
Department
Technology Transfer
Reporting To
Senior Manager
Location
Ambernath
Years Of Experience
10-12 Years
Dosage Form
Solid Orals and / or Nasal
Job Responsibilities / Deliverables
- Strategy for Exhibit batches
Determination of batch size considering equipment capacity and demand volume.
Preparation of material budget for scale up and exhibit batches
Evaluation of change parts/tooling and its procurement.
- Process optimization
Define process parameters during trial / scale up, exhibit, process validation batches. Application of scale up factors and other data to derive process parameters
- Documentation
Prepare/review batch records like BMR & BPR, Prepare/review protocols like process validation protocol, hold time protocol, Product transfer protocol
Prepare/review reports like process validation report, hold time report, scale up report, product transfer report.
- Execution
Manufacturing process optimization / scale up, exhibit, process validation batches at plant Process monitoring of Demo batches at R&D; to evaluate process feasibility at plant
- QMS
Preparation/review of change control for current product, document revision, changes in process etc. Investigation of deviation and OOS -phase II
- Trouble shooting:
To troubleshoot issues related to manufacturing process in commercial products and exhibit batches. Qualifications & Pre-Requisites
M Pharm (Pharmaceutics)
Excellent understanding of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation etc. and nasal operations.
Experienced in handling manufacturing process related troubleshooting.
Experienced in documents (Batch records, PEP/PVP, HTSP, PER/PVR, HTSR etc.)