Copy of Team Leader - QC (Nasal)

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.

Job Summary
We are seeking an individual to lead the stability samples receipt and planning the analysis of stability samples, manage incidents and investigations, approve documents, and ensure laboratory compliance with practices and cleanliness. The role involves procurement of laboratory requirements, instrument qualifications, and calibration.

Roles & Responsibilities

1. Responsible to follow good laboratory and safety practices in the laboratory.
2. Responsible to follow good documentation practices in the laboratory.
3. Responsible to ensure the cleanliness of the laboratory.
4. Responsible to participate and organize equipment/instrument Qualifications & change control mechanism.
5. Responsible to ensure that all the equipment's and instruments are in validated and calibrated state.
6. Responsible to ensure calibration/ performance verification of analytical Instruments and equipment's as per master schedule.
7. Responsible for planning of In-process (IP), Finished Product (FP) and Stability sample analysis with respect to Nasal spray products through Manual/SAP/LIMS.
8. Responsible for planning of packaging material activities with respect to Nasal spray product through Manual/SAP/LIMS.
9. Technical knowledge , Calibration and operation of Spraytec, Sprayveiw for spray pattern , microscope and  viscosity.
10. Responsible to ensure the completion the stability sample analysis within the window period.
11. Responsible to ensure stability studies are executed as per approved stability protocol.
12. Responsible to initiate, investigate and review of incidents, OOS and OOT.
13. Responsible to initiate, review and approval of CRN.
14. Responsible for review of analytical documents.
15. Responsible for approval of STPs, Specifications, SOPs, protocols and Analytical test reports.
16. Responsible to ensure and maintain laboratory analytical standards as per the laid down procedures.
17. Responsible to review and update reference standards against updated catalogues online.
18. Responsible for procurement of laboratory requirements.
19. Responsible to evaluate the instrument/Equipment breakdown as per laid down procedure.
20. Responsible for preparation of response for internal and external audits and other QMS related activities.
21. Responsible for review and approval of record of analysis and analytical test report.
22. Responsible to ensure that the deactivation or destruction of samples as per laid down procedures.
23. Responsible to review and approval the protocols, reports, specification and standard test procedure.
24. Responsible to ensure the implementation of the "Training Program and ensure proper compliance and to train new recruits and impart trainings as a qualified trainer.
25. Responsible to ensure compliance in LIMS related activity and carry out the activities through LIMS (wherever applicable).
26. Responsible to organize contract laboratory audits and certification.
27. Responsible to ensure all the QMS documents like OOS, OOT, and Incident are timely investigated, reviewed and appropriate CAPA's are taken and implemented.

Educational qualification: An M.Sc. degree in Chemistry, Analytical Chemistry, or a related field

Minimum work experience: 10 to 15 years of experience

Skills & attributes:

Technical Skills
• Knowledge of calibration and performance verification of analytical instruments and equipment as per the master schedule.
• Experience in ensuring the maintenance, preparation, and procurement of laboratory standards, chemicals, and solvents according to established procedures.
• Participation and organization of equipment/instrument qualifications and change control mechanisms.
• Procurement expertise for laboratory requirements.

Behavioural Skills
• Attention to detail and commitment to ensuring compliance with QMS documents, including OOS, OOT, and Incident investigations.
• Ability to respond to internal and external audits and participate in other QMS-related activities.
• Strong organizational skills for LIMS related activities.
• Effective communication and collaboration skills for coordinating and implementing CAPAs.

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.

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/#!/