Quality Specialist

Role & responsibilities

1. Shall be responsible for IPQA of one or more manufacturing departments and will be responsible for implementation of Corrective and Preventive Actions.

2. Shall be responsible for ensuring conformance to Process SOPs for concerned product families and making necessary revisions.

3. Shall be involved in preparation of the technical file (device master file) in concordance with applicable regulatory standards.

4. Shall analyse the internal and external rejections on predefined frequencies and identify root causes of rejections and formulate corrective and preventive actions.

5. The corrective action can range from training to process improvements/modification. Training need shall be assessed based on the root cause and communicated to the applicable authority.

6. Shall be a technical resource person for internal and external stakeholders, especially for complex cases.

7. Shall handle escalated quality complaints from CRC.

8. Shall organize and participate in departmental meetings with specific agendas and ensure that each meeting is documented with minutes of each meeting.

9. Shall ensure and perform if necessary, validation procedures and ensure calibration procedures are being performed at prescribed time intervals.

10. Shall perform clinical procedures (only if qualified to) as part of clinical evaluation and process improvement activities.

11. Shall liaise with concerned stakeholders to improve the product and process quality, which may also involve in studying scientific literature.

12. Shall monitor risk-management procedures, and maintain and analyse problem logs to identify and report recurring issues to management and product development.

13. Shall guide the technicians regarding the process and quality.

14. Shall submit required MIS to Sr Quality Specialist/Head of QA at defined intervals.

15. Shall satisfactorily perform any assignments or duties given by concerned Head of QA or Sr Quality Specialist.