Manager/Sr Manager - QA

Aurobindo Pharma; Jadcherla; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Aurobindo Pharma in Telangana is seeking an experienced QA and Compliance professional to oversee cGMP-compliant operations in the General and Oral Contraceptive Block. The role focuses on quality functions, QRM, and regulatory interactions to support audits and inspections.

You will review investigations, CAPA effectiveness, change controls, deviations, and document management activities, coordinating recalls when needed and ensuring timely regulatory submissions.

Aufgaben

• To ensure that operations are carried out in accordance with cGMP & applicable regulations at General and Oral Contraceptive Block at site.
• Responsible for overall Quality Functions and Escalation of Quality issues to Senior Management by conducting QRM as per the procedure.
• Data Integrity review and its Implementation.
• Handling of customers & regulatory inspections, Responsible for Audit coordination and Compliance to the audit Observation.
• Ensure timely submissions of compliance and compliant documents to Regulatory.
• Responsible to review and Approve Investigation of Market Complaints and Product Failures.
• Ensure that a system is available to recall any batch of product from sale or supply & to investigate the reasons for recall.
• Review, Evaluate and verification of effectiveness of CAPA
• Responsible to review and Approve/Reject Process Non-conformance, Material Non-Conformance, Change Control, Exception, Corrective and Preventive actions and closure of corresponding action items. Responsible to act as coordinator for change control and Corrective and Preventive Actions.
• Responsible to review and Approve/Reject Standard Operating Procedures, Protocols/Reports of validation, CPV, Analytical and all Miscellaneous activities, Review and Approval of request initiated for CS user management update for user id creation / modifications, Review/Approval of Master Formula Card, Batch Processing Record, Master Packing Card, Batch Packing Record, Master lists, Schedules, Preventive Maintenance checklists, Training Needs Identification, Matrix Site Master File, ISO Manual, Annual Product Quality review reports / Schedules, GAP Assessments, Quality technical agreements and other documents in Document Management System module.
• Responsible to conduct Mock Recall Exercise.
• Responsible to conduct / Participate in internal/External audits
• Review and approval of Enterprise Risk Management in M7 application.
• Review & Approve Investigations related to Product complaints.
• Review and approval of periodic trends associated with Process Non-Conformance, Out of Specifications, Out of trends, Water and environmental monitoring, Exception, Material Non-conformance and Corrective and Preventive Action and ensure

Jobbeschreibung

1. To ensure that operations are carried out in accordance with cGMP & applicable regulations at General and Oral Contraceptive Block at site.
2. 2. Responsible for overall Quality Functions and Escalation of Quality issues to Senior Management by conducting QRM as per the procedure.
3. 3. Data Integrity review and its Implementation.
4. 4. Handling of customers & regulatory inspections, Responsible for Audit coordination and Compliance to the audit Observation.
5. 5. Ensure timely submissions of compliance and compliant documents to Regulatory.
6. 6. Responsible to review and Approve Investigation of Market Complaints and Product Failures.
7. 7. Ensure that a system is available to recall any batch of product from sale or supply & to investigate the reasons for recall.
8. 8. Review, Evaluate and verification of effectiveness of CAPA
9. 9. Responsible to review and Approve/Reject Process Non-conformance, Material Non-Conformance, Change Control, Exception, Corrective and Preventive actions and closure of corresponding action items. Responsible to act as coordinator for change control and Corrective and Preventive Actions.
10. 10.Responsible to review and Approve/Reject Standard Operating Procedures, Protocols/Reports of validation, CPV, Analytical and all Miscellaneous activities, Review and Approval of request initiated for CS user management update for user id creation / modifications, Review/Approval of Master Formula Card, Batch Processing Record, Master Packing Card, Batch Packing Record, Master lists, Schedules, Preventive Maintenance checklists, Training Needs Identification, Matrix Site Master File, ISO Manual, Annual Product Quality review reports / Schedules, GAP Assessments, Quality technical agreements and other documents in Document Management System module.
11. 11. Responsible to conduct Mock Recall Exercise.
12. 12. Responsible to conduct / Participate in internal/External audits
13. 13. Review and approval of Enterprise Risk Management in M7 application.
14. 14. Review & Approve Investigations related to Product complaints.
15. 15. Review and approval of periodic trends associated with Process Non-Conformance, Out of Specifications, Out of trends, Water and environmental monitoring, Exception, Material Non-conformance and Corrective and Preventive Action and ensure

Preferred candidate profile

Candidate from Pharma Mfg having worked in OSD(Tablets,capsules) primarily having core experience in Audits and Compliance, Market complaints, Investigations.

Handling of customers & regulatory inspections, Responsible for Audit coordination and Compliance to the audit Observation