Officer
Job Description
Purpose
To prepare documents and manufacture scale up and exhibit batches for smooth transfer of pharmaceutical formulations from R&D to manufacturing site.
Position / Job Title
Officer
Department
Technology Transfer
Reporting To
Assistant Manager
Location
Ambernath
Years of Experience
2-3 Years
Dosage Form
Solid Orals and / or Nasal
Job Responsibilities / Deliverables
1. Documentation
Prepare batch records like BMR & BPR,
Prepare protocols like process validation protocol, hold time protocol, Product transfer protocol
Prepare reports like process validation report, hold time report, scale up report, product transfer report
2. Batch Execution
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 protocols.
Identify process challenges during execution and coordinate with concerned departments for resolution.
3. Coordination & Cross-Functional Support
Act as a single point of contact between R&D, Product Development, Manufacturing, QA, QC, Warehouse, and Engineering for smooth and timely execution of batches.
Arrange all necessary prerequisites, materials, equipment, and utilities prior to batch execution.
Ensure timely communication of project status, deviations, and results to stakeholders.
4. Change Control & Investigations
Initiate, track, and ensure timely closure of Change Controls related to product or process transfers.
Compile and analyze process data required for investigations, deviations, and CAPA activities.
Qualifications & Pre-Requisites
B. Pharm / 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.
Basic knowledge of QMS (change control, deviation etc.)
Additional notes
Role is expected to work in all shifts.