Jr. Officer

3 weeks ago

Mohali, Punjab, India Sun Pharmaceutical Industries 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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