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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 ExecutiveDepartmentTechnology TransferReporting ToSenior ManagerLocationAmbernathYears of Experience10-12 YearsDosage FormSolid Orals and / or NasalJob 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)
- Valuable communication skills.

Additional notes

- Role is expected to work in all shifts.

📌 Senior Executive (India)
🏢 Rubicon Research
📍 India