Senior Executive

Lupin; Pithampur; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Lupin is seeking an experienced professional in India to lead technology transfer from R&D to manufacturing. You will drive scale-up activities, pre-validation, process qualification, and batch readiness while reviewing critical documentation and ensuring cGMP compliance.

The role requires 7–8 years in technology transfer with a Pharmacy degree, strong QA/QMS involvement, and cross-functional coordination for regulatory submissions and product launches.

Qualifications

• 7–8 years of experience in technology transfer.
• Experience reviewing BMRs, BMIs, process validation documents, specifications, and R&D documentation.
• Ability to prepare and review protocols, reports, risk assessments, stability studies, and transfer documents.

Responsibilities

• Manage technology transfer of pharmaceutical products from R&D to manufacturing sites.
• Execute scale-up, exhibit, pre-validation, process qualification, and placebo batches; review related documents.
• Prepare and review protocols, reports, risk assessments, stability studies, and transfer docs.
• Handle QMS activities, including Change Controls, Deviations, CAPA, OOS, OOT, investigations.
• Coordinate with cross-functional teams for material planning, regulatory submissions, and product launches.
• Support audits, regulatory inspections, and compliance activities; manage SAP BOM/Recipe creation and process development docs.
• Drive process improvement initiatives and ensure cGMP compliance.
• Prepare SOPs, manufacturing investigations, process flow charts, and yield proposals.

Skills

Technology transfer

Process development

QA/QMS

Cross-functional collaboration

Education

Graduation in Pharmacy

Job description

1. Manage technology transfer of pharmaceutical products from R&D to manufacturing sites.

2. Execute scale-up, exhibit, pre-validation, process qualification, and placebo batches.Review BMRs, BMIs, process validation documents, specifications, and R&D documentation.

3. Prepare and review protocols, reports, risk assessments, stability studies, and technology transfer documents.

4. Handle QMS activities, including Change Controls, Deviations, CAPA, OOS, OOT, OOE, and investigations.

5. Coordinate with cross-functional teams for material planning, regulatory submissions, and product launches.

6. Support audits, regulatory inspections, and compliance activities.Manage SAP BOM/Recipe creation and process development documentation.

7. Drive process improvement initiatives and ensure cGMP compliance.

8. Prepare SOPs, manufacturing investigations, process flow charts, and yield proposals.

Work Experience

7 to 8 Years of Expereince in Technology Tranfser

Education

Graduation in Pharmacy

Developing Talent

Result Orientation

Strategic Agility

Process Excellence

Customer Centricity

Stakeholder Management

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