Sr. No.Job Responsibilities1.To manage and overall administration of Stability Laboratory.2.To manage regulatory and Statutory compliance of Stability Laboratory.3.To manage the quality systems are maintained in the Laboratory and are in compliance with corporate standards and GMP.4.To review and approve OOS, OOT observations, deviations, change control and conduct impact assessment. Inform OOS / OOT results with investigation report to concern site / CQLL.5.To track and ensure timely implementation of CAPA for compliance of CAC audit and Global CAPA as applicable.6.To support in investigation for root cause identification.7.To ensure review of analytical data and Submit Report to manufacturing site EMO.8.To review and approve qualification, validation documents of equipment, system, software's.9.To ensure cGMP trainings and their qualification to personnel at Laboratory. Work for enhancement of analytical technique and efficiency of analyst / Reviewers.10.To report the performance of the quality system in management review meetings and ensure actions are taken based on the discussion for continuous improvement.11.To ensure Personnel Safety in the Laboratory and periodic safety trainings.12.To ensure Self Inspection as per schedule and determine CAPA action items.13.To review and approve compliance report following the external (customer/ regulatory) audit and corporate audit and ensure compliance as per the commitments given.14.Support to other Zydus Sites for Sample analysis.15.Audit and support other site activity as per advice of Lead Central Quality. Participate in due diligence.
