Job Description

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.

Sun Pharmaceutical Industries