PurposeTo facilitate 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 TitleAssociate/ Officer
DepartmentTechnology Transfer
Reporting ToAssistant Manager
LocationAmbernath
Years of Experience1-2 Years
Dosage FormSolid Orals and / or Nasal
Job Responsibilities / Deliverables1. Documentation Preparation
- Preparation of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for Trial batch and exhibit batches.
- Compilation of data for Process Evaluation Report (PER) and Hold Time Study Report (HTSR).
2. Batch Execution & Monitoring
- Coordinate and monitor scale-up, exhibit, and process validation batches at the manufacturing site.
- Ensure all process parameters, in-process checks, and critical control points are followed as per approved BMRs and protocols.
3. Coordination & Cross-Functional Support
- Communicate necessary information to CFTs (QA, QC, FD etc.) whenever required.
- Arrange all necessary prerequisites, materials, equipment, and utilities prior to batch execution.
Qualifications & Pre-Requisites
- M Pharm (Pharmaceutics)
- Knowledge of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation etc. and nasal operations.
Additional notes
- Role is expected to work in all shifts.
