Title:  Manager - 2

RESPONSIBILITY:-

•  To manage activities of RM section. 
•  Provide leadership and direction to ensure the achievement of all RM section.
•  Timely release of In-process, Validation and Product samples.
•  To maintain SOPs related to finished product as per global quality standards and regulatory requirements.
•  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, counselling and performance management of staff.
• Testing of Raw Materials, Stability Sample and Finished products.
• Recording the analytical data in raw data sheet/protocol.
• Ensure standardization of working standards and conduct, preventive maintenance, calibration, qualification of laboratory instruments as and when required.
• Ensure accuracy of document and maintain neat/concise/organized stability record.
• Follow the EHS policy, Laboratory procedure and maintain the compliance to cGMP requirements.
• Initiate the OOS, OOT and deviation & CAPA in Track wise software.
• Destruction of RM/Finished Product/Stability/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.
• Preparation of eCOA /SAP COA/ Regulatory COA as per requirement.
•  Participate in all internal, external and regulatory inspections.
•  Maintain cGMP compliance in the working areas.
•  To ensure qualification of analysts and competency matrices.