Manager - Production

Lupin Ltd; Pune District; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Lupin Ltd in Pune district seeks an experienced professional for biosimilar manufacturing operations. The role targets 11-16 years of experience with M.Sc./B.Tech and Post Graduation, including a B.Tech in Biotechnology or Biochemistry.

You will ensure readiness of equipment, materials, SOPs, process validation, and SAP activities on the shop floor during campaigns. Strong background in biosimilars, production planning and QMS is expected.

Qualifications

• Readiness of equipment and instruments for the process.
• Ensure availability of process raw materials, accessories and consumables in process area before batch execution.
• Preparation, review of process, equipment and area related SOPs and EOPs.
• 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.

Responsibilities

• Readiness of downstream area and other areas like corridors and washing area for manufacturing operations.
• Ensure smooth functioning of shop floor functions during manufacturing campaigns; raise and review change control and deviations as required.
• Handle SAP related activities like process and maintenance.
• Operate downstream equipment for process and CIP/SIP.

Skills

Biosimilar manufacturing

Production planning

QMS

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 regions 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

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