• Responsible for review, tracking and closing of deviation, change control and CAPA in LIMS. • Responsible for participating in investigation along with cross functional team to find out actual root cause of incident or deviation. • Responsible for review and assign number to Deviation, Change control, CAPA when required supporting documents is available in system. • To ensure the completion, closing and effectiveness of CAPA given to the different regulatory and customer audit. • Responsible to take follow up with cross functional team to approval & closing of deviation, change control, CAPA. • To check the effectiveness of implemented change control and CAPA as required. • Responsible for review of manufacturing investigation. • Responsible for handling of Market complaints. Perform investigation and report preparation. • Responsible for review of manufacturing investigation. • Responsible for preparation and review of Risk assessment. • Responsible for logging of conversion note. • Responsible for preparation of Trend analysis report for QMS records as per SOP.
• Responsible for review change control, deviation and CAPA logs from system. • Responsible for handling of recall procedures. • To prepare and revise the departmental SOP and ensure training to all concerns. • To perform mock recall and documented all the activity within timeline as mention in the schedule. • To assist for any other jobs assigned from time to time. • Responsible for FAR handling and sharing investigation report for register market complaints. • To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM. • Perform effective self-inspection as per schedule and ensure timely closing with proper CAPA or justification for the noncompliance found during self-inspection. • To participate in all internal and external audits. • To prepare compliance report of different customer and regulatory audits. • To make sure that internal and external audit compliance report is prepared