Deviation Work:Quality Record Initiation: Initiate quality records promptly and accurately for identified deviations, ensuring alignment with both industry and Catalent expectations.Deviation Investigations: Conduct thorough investigations for identified deviations, employing root cause analysis methodologies.Assess the impact on product quality with input from various departments.Productivity Target: Close a minimum of 2-3 deviations per week to ensure efficient and timely resolution.CAPA Identification and Implementation: Identify and recommend Corrective and Preventive Actions (CAPA) based on investigation findings.Collaborate with stakeholders to ensure the effective implementation of CAPA measures.Weekend Availability: Be available to work on weekends as required, addressing urgent deviations and supporting continuous improvement efforts.Comments Resolution: Timely resolution of internal and client comments related to investigations.Collaborate with relevant parties to address and close out comments effectively.Document Retrieval and Operator Interviews: Retrieve necessary supporting documents to substantiate investigation findings.Conduct interviews with manufacturing operators to gather relevant information.II. Performance Metrics: Performance will be evaluated based on the following metrics:Timely initiation and completion of quality records.Thoroughness and accuracy in deviation investigations.Meeting the minimum requirement of closing 2-3 deviations per week.Effectiveness in identifying and implementing CAPA measures.Availability and responsiveness during weekends.Efficient resolution of internal and client comments.Competency in retrieving supporting documents and conducting interviews.III. Reporting:Regular status reports will be provided by Investigators to relevant stakeholders. These reports will include updates on ongoing investigations, status of CAPA implementation, and any issues or challenges encountered during the process.
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