Manager - Production

Lupin Ltd; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Lupin Ltd in Pune, Maharashtra, seeks a senior professional to oversee readiness of process equipment, materials, and area for manufacturing campaigns, and to manage qualification/validation protocols and study reports.

The role requires extensive experience (11-16 years) in biotech/pharma manufacturing, with degrees B.Tech/M.Sc and knowledge of biosimilar production, production planning, and QMS; SAP involvement on process and maintenance.

Qualifications

• 11-16 years of experience in biotech/pharma manufacturing
• Experience with process qualification/validation
• Experience with SAP-related activities in manufacturing
• Strong understanding of production planning and QMS systems

Responsibilities

• Ensure readiness of equipment and instrument for process.
• Ensure availability of process raw materials, accessories and consumables in the process area before batch execution.
• Prepare and review process, equipment and area related SOPs and EOPs.
• Prepare and execute process, area and equipment qualification/validation protocols.
• Prepare and review reports like process, equipment, area qualification and validation.
• Prepare and review BPR and request issuance of BPR.
• Prepare, review and execute study protocols.
• Ensure readiness of downstream area and other areas for manufacturing operations.
• Support smooth shop floor functioning during manufacturing campaigns; raise and review change controls and deviations as required.
• Handle SAP-related activities for process and maintenance.

Education

M.Sc./B.Tech

Post Graduation

B.Tech in Biotechnology or Biochemistry

Biosimilar manufacturing, Production planning, QMS

Tools

SAP

Job description

Job Description

• Ensure readiness of equipment and instrument for process.
• Ensure availability of the process Raw materials, accessories and consumables in process area before batch execution.
• Preparation, Review of process, equipment and area related SOPs and EOP's.
• Preparation and execution of process, area and equipment qualification / validation protocols.
• Preparation of various reports like process, equipment, area qualification and validation.
• Preparation and Review of BPR.
• Request and Issuance of BPR.
• Preparation, Review and execution of study protocols.
• Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations.
• To ensure smooth functioning of shop floor functions during manufacturing campaigns. To raise and review change control and deviations as per the requirement.
• Handling of SAP related activities like process and maintenance.
• Operating downstream equipment's for process and CIP/SIP.

Qualifications

• 11-16 Years
• 11 to 16 years of experience
• M.Sc./B.Tech
• Post Graduation
• B.Tech in Biotechnology or Biochemistry
• Biosimilar manufacturing, Production planning, QMS