Zydus Lifesciences Limited
Designation : Deputy Manager
Function : Quality Assurance
Functional Area : Topical Formulations QA
Job Role Summary : Handling of Complaints, Recalls, Investigations, Complaint and Recall Alerts, APQR
Job Profile :
- Handling QMS documentations: Change Control, Deviation, Investigation, OOS, OOT, APQRs, Batch Records Review
- Complaints Handling - Logging Complaints, ADEs with complete detail, Investigations, Draft Response, Recommed remediations and recalls, Alert notifications and FAR, coordinate with agency for complaint sample handling
- Responsible for preparation, review and submission of alert notifications to QP for EU, Brazil, South Africa & Japan markets/ to respective regulatory authorities for other markets.
- Handling Recalls and Investigations, Conduct mock recall.
- To prepare and review annual product quality review of the products and ensure compliance to SOP and regulatory requirements.Â
- Support to Regulatory Affairs. Data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data, collecting stability data and reports for product related evaluations, variation and market authorization if any as per APQR/PQR site SOP,
- To verify the data / information provided in the Technology transfer document for its completeness, relevance and scientific basis, as per applicable guidelines.
- To review and ensure Technology Transfer of Products at site and ensure preparation of Summary report post completion of Engineer and Exhibit batches.
Job Requirements :
- Experiences: 7 to 15 years
- Experience Handling Market Complaints, Adverse Events (ADE), Alert and FAR Notifications, APQR and Documentation support to RA
Work / Job Experience : 7-15 Years
Type of Experience : QA
Academic Qualifications :
B.Pharm / M.Pharm
