Skill: capa , usfda , customer complaints; Exp: 0-3 years; Perform product compliant investigations in a timely manner to conduct compliant investigations, determine root cause and implement CAPA’s as appropriate Acknowledgement of complaints. Review of Batch records, trend of complaints, trend of exception reports, Evaluation of retain samples with respect to the complaint condition, Confirmation of customer complaint, Containment Actions (initiation of quality Hold), determine the need for FAR or notification to regional quality. Preparation of initial Field Alert Report to USFDA/ Notification to regional quality. Initiate further investigation , conducting initial impact assessment (IIA) within 3 business days, Evaluation of customer returned sample, Complete investigation to determine root cause, Determination of Corrective and Preventive Actions, Initiation of medical assessment as necessary. Preparation slide deck for the periodic management review Evaluation of the compliant for the specific period , review for potential trends, escalation of potential issues to management. Periodic submission of FAR/regional quality notification reports with the key investigation findings to meet regulatory commitments. Complete review of ER investigation to ensure adequacy and compliance Disposal of quality holds (if any). Preparation of AQRT executive summary for the high risk issues pertaining to customer complaints. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Function: Quality / Process Control