Sun pharma jobs; Executive-QA of QC
Executive-QA of QC
Location: Mohali – Quality Assurance
Company: Sun Pharmaceutical Industries Ltd
Job Description;
- Implement, operate, monitor, and maintain Quality Systems enabling on-site operations to occur efficiently and comply with Global Quality Standards and cGMP.
- Review and Archival of Quality System documents.
- Follow up for timely closure of Quality Management System documents.
- We are participating in the investigation analysis for Deviations, OOS, OOT, Complaints, and Audit findings.
- Review and approve the QMS records (OOS, OOT, Lab event, Investigation, CAPA) in the Trackwise system.
- Review and approve change control requests, specifications, standard test procedures, and SOP in Documentum Compliance Manager System.
- Supporting external audits preparations and responding to audit findings.
- Compilation of the Internal audits response and follow-up.
- Assist in scheduling and preparation of management review meetings.
- Organize the CAPA meeting, coordinate/manage CAPA efforts and interact with customers to conduct complaint investigations.
- Assist in authoring, reviewing, and updating quality procedures as applicable.
- To compile & present the data for product robustness to senior management
- Responsible for 21st-century quality initiative activities
- Analytical Data Review
- QMS Record Management (Lab Event, OOS, OOT, Investigation, Unplanned Deviation, Planned deviation)
- 21st Century Quality Initiative Activities
- Internal/External Audit Readiness
- Active participation during Internal/External Audit