Senior Executive

Purpose To 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 Title Senior Executive 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

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.