Executive

8 months ago

Mohali Punjab, India Sun Pharmaceutical Industries Ltd 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.
- To ensure qualification of analysts and competency matrices.
- Responsible for effective managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals
- Destruction of Stability / Finished Product/ Validation/In-process/Swab samples after completion of analysis and review of the data.
- Ensure integrity, accuracy and adequacy of the analysis performed.
- Recording of instrument and standard usage in the respective log books/registers.
- To perform the analytical method transfer activity as and when required.
- Preparation of eCOA /SAP COA/ Regulatory COA as per requirement.
- Data punching in Novatek Software.
- To correct the document observation on time given by QA of QC reviewer.
- Any other Assignment given by Lab in charge/ Manager Quality Control from time to time.
- Conduct date-in, date-out and inventories of stability samples in line with SOP.
- Daily monitoring of stability chambers.
- Review calibration certificates, calibration and preventive maintenance record etc. for accuracy and completeness.
- To prepare, execute and review protocols of calibration, mapping and qualification of stability chamber.
- Ensure periodically qualification, calibration and preventive maintenance of stability chamber.
- Ensuring all stability chambers qualified, monitored and suitable for intended use.
- Performing samples receipt, incubation, withdrawal, inventory, and destruction.
- Label printing, label pasting and bar code scanning, charging and withdrawal of stability samples.
- Printing stability samples scheduler.
- Physical inventory verification of charged stability samples.
- Conducting the stability study as per approved stability protocol.
- Ensure compliance to cGMP requirements and laboratories procedures.

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