We're
looking for a Senior Professional from QA dept for our prestigous API Unit
situated at Vizag. Intersted one can share their profiles to vinay.bura@aurobindo.com
Looking For Sr. G.M /
A.V.P - QA for Vizag Unit (API-division)
*Comprehensive
leadership experience in managing the entire Quality Assurance function at a
regulated site & maintain quality systems meeting cGMP/cGLP standards.
*Monitor the qualification and validation activities of facility, equipment and processes and ensure compliance to the documented procedures.
*Ensure the DMF fillings from the site are complying with the regulatory standards and the products comply with all the necessary quality and regulatory requirements prior to filling the DMF.
*Sound knowledge in QMS implementation, Validation protocals, Vendor qualification, Audit Mgt and Risk management.
*Inspecting Vendor activities with high quality standards with a view to ensure timely accomplishment of targets within the time and cost parameters.
*Ensure Root Cause Analysis, Change Controls & Deviations, APRs and EQ managing Administrating & leading, motivating the team to get in line with regulatory guidelines and to get effective implementation of integrated quality management system.
*Should be successful in handling all regulatory inspections like USFDA, EU, EDQM, TGA, COFEPRIS etc.
*Monitor the qualification and validation activities of facility, equipment and processes and ensure compliance to the documented procedures.
*Ensure the DMF fillings from the site are complying with the regulatory standards and the products comply with all the necessary quality and regulatory requirements prior to filling the DMF.
*Sound knowledge in QMS implementation, Validation protocals, Vendor qualification, Audit Mgt and Risk management.
*Inspecting Vendor activities with high quality standards with a view to ensure timely accomplishment of targets within the time and cost parameters.
*Ensure Root Cause Analysis, Change Controls & Deviations, APRs and EQ managing Administrating & leading, motivating the team to get in line with regulatory guidelines and to get effective implementation of integrated quality management system.
*Should be successful in handling all regulatory inspections like USFDA, EU, EDQM, TGA, COFEPRIS etc.
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