Manager - Production

Lupin Ltd; Pune District, Pimpri-Chinchwad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Lupin Ltd in India seeks a senior professional for equipment readiness, SOP/EOP review and process validation in biosimilar manufacturing. You will ensure materials and downstream readiness and handle SAP processes on the shop floor.

The role requires 11–16 years of experience in biosimilar manufacturing, production planning and QMS, with a BE/BTech and MSc or higher. Training and compliance are key.

Qualifications

• 11–16 years of experience in biosimilar manufacturing.
• Experience with process, equipment and area qualification/validation.
• Strong documentation and reporting background.

Responsibilities

• Ensure readiness of equipment and instrument for process.
• Ensure availability of process raw materials and consumables in process area.
• Prepare and review SOPs and EOPs for process, equipment and area.
• Prepare and execute process/area/equipment qualification and validation protocols.
• Prepare and review reports on process, equipment, area qualification and validation.
• Prepare and review BPR and issue BPR.
• Prepare, review and execute study protocols.
• Ensure readiness of downstream area and other areas for manufacturing operations.
• Support smooth shop floor operations during campaigns; raise/review change controls and deviations.
• Handle SAP-related activities for process and maintenance.
• Operate downstream equipment for process and CIP/SIP.

Skills

Process readiness

SOP & EOP review

Documentation

Education

M.Sc./B.Tech

Post Graduation

B.Tech in Biotechnology or Biochemistry

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.

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.

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.

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