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- 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.
Executive - Sahibzada Ajit Singh Nagar, India - SUN PHARMA
Description
RESPONSIBILITY: