Senior Executive- Documentation
5 hours ago
Position / Job Title
Sr. Executive
Department
Manufacturing (Documentation)
Location
Ambernath
Years of Experience
5-7 years
Dosage Form
Solid Orals and / or Nasal
Job Responsibilities / Deliverables
- Preparation of batch manufacturing and packing records (BMR & BPR) for routine commercial batches.
- Preparation of batch manufacturing and packing records (BMR & BPR) for intended commercial batches for regulatory submission.
- Preparation of process validation protocols and reports (PVP & PVR) for commercial batches.
- Preparation of hold time study protocols and reports (HTSP & HTSR) for commercial batches.
- Preparation of QMS documents (change control, deviation, CAPA, OOS investigation report etc.).
- Arrangement of applicable prerequisites for any new product document preparation.
- Coordination with R&D, PD, and MFG. QA, WH, QC etc. for timely documentation and execution of commercial and process validation batches.
Qualifications & Pre-Requisites
- B. Pham/M Pharm.
- Knowledge of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, and Capsulation etc.
- Knowledge of operations in Nasal formulation will have added advantage.
- Experienced in document preparation (Batch records, PVP, HTSP, PVR, HTSR etc.)
- Knowledge of QMS handling (change control, deviation, CAPA, OOS investigation)
- Knowledge of SAP system related to work.
- Good communication skills.
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