Senior Executive- Documentation

5 hours ago

Mumbai, Maharashtra, India Rubicon Research Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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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