Sr Manager Quality Assurance in Pharma

Job Description :

•  Responsible for preparation of quarterly and annual trends for Out of Specifications, out of trends, Process non-conformance, exceptions and initiating comprehensive investigations wherever applicable.
•   Responsible for initiation of change controls, CAPA, process non-conformance and investigation reports.
•  Responsible for preparation of protocols and reports for the studies triggered due to regulatory requirements / queries.
•  Responsible for preparation of Elementary impurities and nitrosamine impurities risk assessment reports.
•  Responsible to provide analytical data to regulatory affairs department as and when required.
• Responsible for timely closure of CAPAs, Change controls and process non-conformances.
• Responsible for status change of raw material and packaging material in ERP based on the QMS documentation and coordinating with cross functional departments as and when required.
•  Responsible for timely qualification and re-evaluation of contract testing laboratories as per the schedule and updating the relevant formats.
•  Responsible to ensure timely training on all the required SOPs.
•  Timely inspection and unannounced rounds of QC laboratory.