Executive Process Development (TT) (Pithampur)

Executive Process Development (TT) (Pithampur)

26 Oct
|
LUPIN
|
Pithampur

26 Oct

LUPIN

Pithampur

Job Title: Executive Process Development (Technology Transfer)

Company: Lupin Limited

Department: Process Development

Location: Pithampur (Indore), Madhya Pradesh

Experience: 7 to 8 years in formulation tech transfer / process development

Qualification: M. Pharm / B. Pharm

Key Responsibilities:

- Support technology transfer of drug products from R&D; to the manufacturing site, and from one site to another.
- Plan and execute experimental, processed/unprocessed placebo, scale-up, pre-validation, exhibit and qualification batches.
- Prepare and review batch protocols and reports for experimental, scale-up and pre-validation batches.
- Review master BMR/BMI, process qualification protocols and reports, and RM, IP and FP specifications.
- Prepare and review elemental impurity and nitrosamine risk assessment reports.
- Review hold time studies, APQR, transportation studies, equipment qualification and cleaning validation documents.




- Review stability protocols for exhibit, commercial and development batches.
- Initiate SAP input data requests (BOM/Recipe) for placebo, exhibit and commercial batches.
- Coordinate with R&D;, Manufacturing and GSCO/GSCM so that RM/PM are available on time.
- Handle QAMS: change controls, deviations and CAPA.
- Review investigations for OOS, OOT, OOE, IPOOS, deviations and market complaints.
- Support regulatory audits and inspections, and audit compliance.
- Contribute to process improvement projects, yield proposals and process flow charts.
- Provide complete documentation to QC, QA and RA for tech transfer, regulatory filing and product launch.
- Follow cGMP, GDP and EHS requirements, and complete training on relevant SOPs.

📌 Executive Process Development (TT) (Pithampur)
🏢 LUPIN
📍 Pithampur

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