Team Leader

Description
Should be responsible for batch release
Monitor stability schedule and ensure analysis is performed timely
Review of Specification and STP
Preparation and review of SOP
Raw Data review review for Finished product batch release
Preparation of various protocols such as stability study, hold time study, photostability study, Freeze thaw study
Participate in OOS/ OOT and deviations investigations and ensure timely closure of the same.
Support RA department by providing all the required documents for product filing
Ensure VQ is done for all RM,PM,API suppliers and maintain record for the same.
Ensure compliance of the AMV laboratory, software qualification of various instruments in AMV lab
Should visit CMO/CTL for data review
Ensure qualification of equipment done
Qualifications
Should have worked in relevant area for at least 5 years
Should be well versed with QC instrument software's, LIMS, QMS software
should possess good analy...