Senior Executive

Lupin Ltd; Dhar; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Lupin Ltd in India is seeking a seasoned professional to manage technology transfer from R&D to manufacturing. You will coordinate cross-functional teams and ensure cGMP compliance.

The role requires 7–8 years in technology transfer and a Pharmacy degree, with exposure to QMS, regulatory submissions, and process development.

Qualifications

• 7-8 years of experience in technology transfer.
• Bachelor or higher degree in Pharmacy with relevant experience.

Responsibilities

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

Skills

Technology transfer

Pharma manufacturing

GxP compliance

Cross-functional teamwork

QA/QMS

Education

Graduation in Pharmacy

Tools

SAP

Job description

Job Description

• Manage technology transfer of pharmaceutical products from R&D to manufacturing sites.
• Execute scale-up, exhibit, pre-validation, process qualification, and placebo batches.Review BMRs, BMIs, process validation documents, specifications, and R&D documentation.
• Prepare and review protocols, reports, risk assessments, stability studies, and technology transfer documents.
• Handle QMS activities, including Change Controls, Deviations, CAPA, OOS, OOT, OOE, and 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 documentation.
• Drive process improvement initiatives and ensure cGMP compliance.
• 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

Competencies

• Developing Talent
• Innovation & Creativity
• Result Orientation
• Strategic Agility
• Process Excellence
• Customer Centricity
• Collaboration
• Stakeholder Management