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.
