Team Member - QA QMS

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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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 software’s.
   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 software’s.
   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.

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

Benefits Offered

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

The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/"