Manager - Downstream Production

Lupin · Pune district, India

• To supervise and participate in downstream operations for Microbial Production.
• To ensure smooth functioning of shop floor functions during manufacturing campaigns. To raise and review change control and deviations as per the requirement.
• Responsible for compliance with cGMP and related elements like facility documentation, trainings, reports, records during manufacturing operations.
• Review of GMP documents related to manufacturing operations like SOPs, EOPs, BPRs Protocols, etc. and to perform required correction for betterment.
• To track and monitor equipment and facility qualification, requalification, process and cleaning validation.
• Participation in GMP audit and internal audits. To ensure process and facility always under the state of cGMP compliance
• Personnel safety compliance in co-ordination with EHS team.
• Participate in investigations and Quality Risk assessments.
• Ensure up-keep of the manufacturing facility, equipment WRT AMC, PM and Calibration.
• To participate in technology transfer from R&D to manufacturing.
• To provide coaching, development and training of juniors.
• To participate in projects like plant modification, capacity expansion, etc.