Senior Manager - AD Central Analytical Lab

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Job Description:

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Provide strong leadership and expertise for the Laboratory investigation team and to provide scientific support & rational to the group w.r.t QMS

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Provide opinion to team leads in case of any discrepancy during scientific review of incoming key Analytical methods or while protocol preparation by individual team lead. 

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To lead and support the troubleshooting investigation for any failure observed during AMV or AMT studies

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Trouble shooting / Training of analyst as and when required.

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Lead and Co-ordinate for scientific query related activities which needs support to plan in the development laboratory.

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Support to review the scientific technical justifications in case any failure observed during AMV/AMT study.

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To ensure for implementation of SOP, GLP and Safety practices in laboratory. 

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Review and approval of standard operating procedure and other QMS documents as applicable.

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Ensure for compliance in the laboratory

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Responsible for handling internal and external audit in lab.

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Preparation of response for the compliance of observation (if, any) during QA lab round or internal and external audit. 

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Responsible for maintaining lab inventory and CAPEX w.r.t GLP

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Any other responsibilities assigned as on when required.    

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Degree in Science, Pharmacy or relevant field