Team Member - QA QMS

Educational Qualification

Graduation in Pharmacy

Minimum Work Experience

8+ years of experience.

Skills & Attributes Functional Skills

. Change Control Coordinator

Market complaint investigator

APQR

Resident Skills

• Current Good Manufacturing Practices (cGMPs)
• 21 CFR Part 210 and 211

Behavioural Skills

• Technical leadership guides teams in solving complex challenges and driving automation excellence.
• Continuous improvement mindset – fosters a culture of proactive problem-solving, learning, and cost-effective innovation.

Critical Exposures

• 8+ years in roles across QMS systems and Market Complaint investigations

Roles & Responsibilities:

1. Handling of QMS activities like change control, Deviations, CAPA, Market complaints Recalls and Returned goods as per the predefined procedure product as per procedure.
2. To involve in Regulatory filings and query response.
3. To access Cross site applicable CAPA at site.
4. To ensure compliance of SOP for closure of Deviations within timelines.
5. To carryout Deviation/Market Complaint/CAPA trends as per procedure.
6. To involve in the Management of Risk Assessments and Risk Summary.
7. Review of all logbooks used in Production, Packing, Quality Control, Engineering & Warehouse area.
8. Ensure the compliance in the manufacturing facility or area with respect to the cleanliness, and labelling as per the cGMP.
9. Responsible to carry out the investigations and timely closure of the same within the time line.
10. To involve in QRM and Tracking actions periodically.
11. To Carry out any other job assigned by the Head of the Department, Quality Assurance.
12. To carry out the Document life cycle management as per the approved procedure and applicable softwares.
13. Annual Product quality review.
14. To participate in handling of internal and external audits (Customers/Regulatory agencies). Coordinate with plant QA for preparation of response and appropriate CAPA.
15. Responsible to evaluate the gaps, with respective to current regulatory expectation and observations in pharmaceutical industry.
16. Initiation and handling of Quality Notification of Deviations, CAPA, OOS & OOT/FAR/QDN/Recall and Change controls through applicable softwares.
17. Review of change controls through as per applicable software.
18. Responsible for participation in the investigations i.e. OOS, OOT, Deviations and ensure its closures within the timelines.
19. Periodic review of the area, equipment and the instruments are in validated and calibrated state.
20. Review of SOP’s, Protocols, Reports, Qualification documents, Deviations/OOS/OOT/Market Complaints/Recalls/FAR/QDN.
21. Responsible for co-ordination with RA for Data Submission.
22. Responsible for maintaining the licenses and Quality Technical Agreements and communication to SCM and RA personnel for license updation.