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 TitleSenior Executive
DepartmentTechnology Transfer
Reporting ToSenior Manager
LocationAmbernath
Years of Experience10-12 Years
Dosage FormSolid Orals and / or Nasal
Job Responsibilities / Deliverables
- Preparation of batch records for exhibit batches (BMR & BPR).
- Preparation of protocols (PEP & HTSP) and reports (PER & HTSR) for exhibit batches.
- Preparation of QMS documents (change control, deviation / OOS investigation report etc.).
- Process monitoring for scale up, exhibit and process validation batches.
- Arrangement of applicable prerequisites for scale up, exhibit and process validation batches.
- Coordination with R&D, PD, MFG. QA, WH, QC etc. for timely execution of scale up, exhibit and process validation batches.
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.
- Experienced in document preparation (Batch records, PEP/PVP, HTSP, PER/PVR, HTSR etc.)
- Knowledge of QMShandling (change control, deviation / OOS investigation)
- Good communication skills.
Additional notes
- Role is expected to work in all shifts.
