Executive

4 weeks ago


Sahibzada Ajit Singh Nagar, India SUN PHARMA Full time

RESPONSIBILITY:

To manage activities of finished product & Stability section. Provide leadership and direction to ensure the achievement of all finish product & Stability section. Work allotment, sample management and timely analysis of commercial In-Process, validation, finish products & Stability Samples. Timely release of In-process, Validation and Finish Product samples. To ensure completion of analysis of commercial stability samples within the window period. Ensure compliance in testing and release for commercial stability and finished product as per cGMP standards. To maintain SOPs related to finished product as per global quality standards and regulatory requirements. To ensure date in, date out and inventories of stability sample in line with SOP. To support QA systems and process related to data review. To support regulatory operation for timely submission. Responsible for laboratory investigation and root cause of OOS, OOT, deviation and implementation of CAPA accordingly. Periodic review of related log books. To ensure execution and review of protocols of calibration, mapping and qualification of stability chambers and other instruments. Coordination for analytical method transfer and review of respective records. Maintain and report quality matrices for commercial finish product and stability sections. Monitor performance and set improvement areas. Determine resource needs (staff, instruments, lab space etc.) and manage organizational development including interview and selection, mentoring, coaching, counseling and performance management of staff. To impart training to QC users as per requirement. Participate in all internal, external and regulatory inspections. Maintain cGMP compliance in the working areas. To ensure timely destruction of samples after completion of analysis.
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