Reckitt Benckiser - Assistant Manager - Quality Assurance

Responsibilities :

1. To monitor the site quality system compliance requirement of Schedule M, MHRA, SAHPRA, ISO 9001 and other regulatory authorities. IPQA, Manufacturing and packaging, shopfloor experience is mandatory.

2. To Monitor planning and conduct of Self Inspection. Initiate and approve the corrective action plans. Compliance follow-ups for external audits.

3. Investigate, review Deviations, Quality incidents and ensure adequate CAPA plans, its implementation and close-out in Quality One software.

4. Ensure change controls are initiated, reviewed, & documented in Quality One software.

5. Investigate, review consumer complaints & ensure appropriate CAPA implementation.

6. Monitor the annual supplier audit schedule, Assessments and conduct audits for raw material and packing material suppliers as per schedule.

7. Lead and manage the local Quality Assurance team.

8. Ensure that finished products released as per the release procedure

9. Review and approval of Supplier based on document assessment and audit outcome

10. Prepare audit compliance reports and ensure CAPA in co-ordination with suppliers

11. Monitor the Out of Specification & Out of trend results investigations

12. Review audit trails for laboratory instruments.

13. Review and approval of batch records and release of FG.

14. Review, approve the Quality assurance SOP's

15. To review the site policy and procedure's like VMP, SMF, PVMP, Protocols, specifications, test methods, batch documents & other site documents.

16. Trend analysis of quality management system key performance indicators.

17. To ensure that appropriate qualification, requalification and validations are done for site equipment, area, and systems.

18. To control, maintenance, and issue of documentation for manufacture, compliant with the marketing and manufacturing authorizations requirements (regulatory bodies) and effective/efficient delivery of operational activities.

19. To ensure the management review and annual product review program are maintained according to concerned GMP and QMS requirement.

20. Ensure store checks are performed timely.

21. To manage Quality Critical Event. To contribute as a member of quality critical event for reviewing of decision for the event such as continuing production and sales and level of recall etc.

22. To ensure and monitor key quality process during NPD/EPD roll out from site.

23. Ensure appropriate qualification and validations for site equipment's, area and systems

24. Ensure required initial and continuing training of department personnel & adapted according to need. Provide GMP trainings.

25. To support all key initiative at the site as key member of the Site leadership team.

26. Site Management review meetings & ensure completion of follow up actions.

27. Motivate and drive the Quality team to continually improve the Quality Culture at site.

28. To perform, review of the site risk register and evaluation.

29. Ensure the monitoring and control of the manufacturing environment, plant hygiene, process validation, training.

30. To understand all environmental & safety standard requirements and provide guidance to team.