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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Compile annual product quality reviews (APQRs) per applicable SOPs. Collect, analyse & summarize product review data correctly & completely Assist Apotex in the preparation & support activities related to APQRs for regulatory& customer audits, as required Profile DescriptionPerform Annual Product Quality Reviews (APQRs)as assigned. This includes the following at minimum, as per SOP : o Manufacturing Process Overview o Batches Released / Rejected o APIs, Excipients o Changes o Test Method and Specification o Manufacturing / Process Validation, Equipment and Utilities Qualification o Sterility Validation / Qualification (If applicable) o Packaging Component Deviations/Changes o Compendial Review o Deviations o Critical In-Process Attributes o Analytical Test Results o Recalls and Field Alerts, Returns o Retention Samples Review o Technical Agreements (as appropriate) o Marketing Authorizations Variations and Post Market Commitments (as appropriate) o Complaints o Stability o Conclusion and Product Rating o Concerns, Recommendations and Issues for Follow-Up Perform complete & correct transactions of the data as per SOP / WIs. Summarize & trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review and accepted by the ARPL COE Reviewer and Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leaders queries for APQR summary reports as required. Assist in preparation, review & revision of Standard Operating Procedures (SOPs) as required. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements & established safety standards. Work both independently & as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business & quality standards.,
Keyskills :
productquality customeraudits ts qualityreviews processvalidation manufacturingprocess ummaryrep