Manager - Quality Assurance

Job Description

1. Overall responsible for all Quality Assurance related activity (developmental and manufacturing QA activities)
2. Responsible for implementation and maintenance of cGMP/GLP in factory premises such as Manufacturing, QC, purchase, warehouse, engineering area.
3. To continuously review quality assurance processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements, and making recommendation for improvement as appropriate.
4. Maintain and improve departmental operational performance, to meet the requirements of external and internal customers, with respect to quality, service, lead time and cost.
5. Manage and control all quality assurance activities in accordance with the company procedures, client specifications and contract requirements.
6. Establish and maintain a quality management system that supports GMP compliance including quality polices and SOPs.
7. To ensure the data integrity in line with national and international regulatory guidelines.
8. Handling of customer audits and regulatory agency inspections.
9. Lead the inspection readiness program for areas of responsibility including training, mock audits, SME preparation and inspection management.
10. To ensure audit response are sent to regulatory agency and customers in timely manner.
11. Review and approve audit response and evaluate adequacy of corrective and/or preventative actions.
12. Handling of deviations, change controls, non-conformances, OOS, market complaints, product recalls, OOT & OOC etc.
13. Conducting investigations using Root cause analysis tools, such as FMEA, fishbone diagram etc.
14. Periodic review of Quality management systems and Annual product review.
15. Ensures implementation of effective CAPAs to prevent recurrence.
16. To ensure the qualification and maintenance of premises and equipment.
17. Batch Release
18. Rejection of Raw Material, packing material and finished goods.
19. To ensure that the stability programs are conducted as per the ICH guidelines.
20. Performing vendor audit for Raw material/ / Contract manufacturing site & laboratories/ External Service Provider.
21. Auditing of third party manufacturing sites as per the company requirement
22. Quality initiative at manufacturing site
23. Review and approve FAT, URS, IQ, OQ and PQ documents.
24. To ensure the qualification and maintenance of premises and equipment conducted on timely manner.
25. Review and approve preventive maintenance and calibration programme.
26. Review and Approve process validation, APQR, Validation and calibration of area/ equipment/ instruments, CMD, CMV, AMD, AMV, AMT, Method equivalency, stability protocol, quality agreement and specification etc.
27. Present quality data and metrics at Management Review meetings.
28. Present critical QMS events to Management on monthly basis.
29. Create and maintain the training management programs and ensure trainings are conducted as per the scheduled program.
30. Approval of written procedures and other documents, including amendments.
31. Monitoring and control of the manufacturing environment.
32. Maintaining plant hygiene.
33. To evaluate the customer feedback and satisfaction
34. Responsible for management of the document management and archival system.
35. Responsible for quality functions of ISO 9001:2015 & ISO 13485:2016.
36. Providing direction and guidance to the Quality team.
37. Preparing and justifying the Quality departments budget.
38. Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
39. Manpower handling and work management.
40. Selection and recruitment of employee (Interview panelist)
41. Undertaking any other duties, either for this department or any other department within the business, which may be requested by the management, for which training and/or an explanation has been provided and understood.

Secondary Responsibilities:

1. To approve the formulation & development related activities in the absence of F&D Head.
2. To approve the Quality Control related activities in the absence of QC Head.
3. Responsible for supporting the development and maintenance of a customer focused culture within the organisation.
4. Support the development of quality goals and targets as part of the organisations strategic plan
5. Carry out, as instructed, any task as deemed reasonable by the Director in the interest of the organisation.

Keyskills :
vendor auditroot causequality assurancequality management systemcontinuous improvement facilitationmanpower handlingbatch releasecustomer focusquality controlmusic makingquality assurance processesdata integritycustomer auditsmanagement syste