Team Member QA QMS

Roles & Responsibilities:

1. 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 SOPs 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.

Qualifications :

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

Additional Information :

Benefits Offered

At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

For more details please visit our career website at Work :

No

Employment Type :

Full-time