About the Role

We are looking for an Executive in Process Development (Technology Transfer) to move drug products from R&D; to commercial manufacturing, and between manufacturing sites. You will plan and run batches and handle the documentation that supports regulatory filings, all in line with cGMP.

Responsibilities

- Facilitate 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 train team members on relevant SOPs.

Qualifications

- M. Pharm / B. Pharm

Experience

- 7 to 8 Years

Required Skills

- Technology Transfer, Scale-up, Exhibit Batches, Process Validation, Risk Assessment, QAMS, OOS/OOT Investigation, SAP, cGMP, Regulatory Audits

Salary Range

- up to 9 LPA

📌 Executive (Indore)
🏢 LUPIN
📍 Indore