PurposeTo facilitate preparation of documents required for manufacturing and packing of pharmaceutical products in regulatory compliant environment. Right first time documentation like batch manufacturing and packing record, Process validation protocol and record and quality management system documents for manufacturing of products with right quality and quantity.
Position / Job TitleSr. Executive
DepartmentManufacturing (Documentation)
Reporting ToAsst. Manager
LocationAmbernath
Years of Experience5-7 years
Dosage FormSolid 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 QMShandling (change control, deviation, CAPA, OOS investigation)
- Knowledge of SAP system related to work.
- Good communication skills.
Additional Notes
- Role is expected to work in all shifts.
