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