Executive

Lupin; Indore District; On-site; INR 810,000 - 990,000; Full time

Job summary

Lupin in Indore is seeking an Executive in Process Development (Technology Transfer) to move drug products from R&D to commercial manufacturing and between sites. You will plan and run batches and assemble documentation supporting regulatory filings, ensuring cGMP compliance.

Key duties include tech transfer coordination, batch planning, review of protocols and reports, handling QAMS and CAPA, audits support, and driving process improvements.

Qualifications

• Degree in pharmacy (M. Pharm or B. Pharm) required.
• 7–8 years of experience in process development/tech transfer.
• Experience with QMS, CAPA, deviations, audits and cGMP.

Responsibilities

• Transfer technology from R&D to manufacturing sites.
• Plan and execute batches: process/scale-up/pre-validation.
• Prepare batch records, reviews, and regulatory documentation.
• Review master BMR/BMI, process qualification protocols and reports.
• Review hold time studies, APQR, transportation studies, equipment qualification and cleaning validation documents.
• Review stability protocols for exhibit, commercial and development batches.
• Coordinate SAP input data requests (BOM/Recipe) for placebo, exhibit and commercial batches.
• 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.

Skills

Technology Transfer

Scale-up

Exhibit Batches

Process Validation

Risk Assessment

QAMS

OOS/OOT Investigation

SAP

cGMP

Regulatory Audits

Education

M. Pharm / B. Pharm

Job description

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