27 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