Job Description

Department DetailsRole Summary

• To head downstream microbial manufacturing operations, packaging & shipment of drug substance
• Adherence to campaign plans, batch releases and cGMP compliance to all campaigns undertaken in GPP plants.
• Compliance to EHS (Environment, Health and Safety) practices and knowledge on statutory requirements .
• Monitoring of process performance and campaign reviews for validated processes and suggest continual improvement initiatives.
• Ability to carry out in-depth technical investigation along with MSAT and implement appropriate CAPA for deviations within manufacturing.
• Responsibility of technology transfer of products and processes into and out of manufacturing plant.
• Ensure any time audit readiness and good knowledge on PDR technical reports, EU and FDA guidelines.
• To host and represent manufacturing operations in regulatory and safety audits, and ensure compliance to findings and audit queries.
• To mentor team members, discuss career path and review performance of team at regular intervals.
• Represent manufacturing operations in relevant discussions & meetings with partners and clients.
• Discussions with Cross Functional departments to ensure smooth functioning of the plant and timely release of batches.

Key Responsibilities

• To head downstream microbial manufacturing operations, packaging & shipment of drug substance
• Adherence to campaign plans, batch releases and cGMP compliance to all campaigns undertaken in GPP plants.
• Compliance to EHS (Environment, Health and Safety) practices and knowledge on statutory requirements .
• Monitoring of process performance and campaign reviews for validated processes and suggest continual improvement initiatives.
• Ability to carry out in-depth technical investigation along with MSAT and implement appropriate CAPA for deviations within manufacturing.
• Responsibility of technology transfer of products and processes into and out of manufacturing plant.
• Ensure any time audit readiness and good knowledge on PDR technical reports, EU and FDA guidelines.
• To host and represent manufacturing operations in regulatory and safety audits, and ensure compliance to findings and audit queries.
• To mentor team members, discuss career path and review performance of team at regular intervals.
• Represent manufacturing operations in relevant discussions & meetings with partners and clients.
• Discussions with Cross Functional departments to ensure smooth functioning of the plant and timely release of batches.

Educational QualificationsRequired Education Qualification: B.Tech
Required Experience: 0 - 3 years

Biocon