Senior Executive

Responsible for review and assign number to Deviation, Change control, CAPA when required supporting documents is available in system. Responsible for 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. 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 preparation and review of Risk assessment and proving number to Risk assessment document. Responsible for logging of conversion note. Responsible for preparation of Trend analysis report for QMS records as per SOP. Responsible for review of change control, deviation and CAPA logs from system. Responsible for handling of recall procedures. To perform mock recall and documented all the activity within timeline as mention in the schedule. Responsible for FAR handling and sharing investigation report for register market complaints. To participate in all internal and external audits. To prepare and review of Site Master File and Quality Manual. Preparation, Review, Issuance, Revision, Control and Retrieval of SOP pertaining to functioning of the department. To assist for any other jobs assigned from time to time by HOD."