Team Member - MQA

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.

Roles & Responsibilities

• To review and approve all microbiological test results
• Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to microbiology and sterility assurance.
• Responsible to carry out the investigations related to microbiology and sterility assurance and timely closure of the sane within the time line.
• Preparation and review of’ SOP’s
• Monitoring of key performance indicators (log books, ROAs and practices against SOPs) related to microbiology.
• Ensuring the compliance of Audit observations related to microbiology and sterility

• assurance.

• To review analytical method development, process validations, cleaning, validations, method suitability studies, area qualifications, various miscellaneous microbiological validation activities, process simulation studies. Review of above protocols and reports related to microbiological analysis.
• To review trends as applicable and to recommend any changes for the better control of the system.
• Participate as a coordinator/team member in Sterility Assurance activities.
• Review STPs and Specifications, review and approval of record or analysis and analytical test report.
• Review of Sterility assurance activities Viz.. unit operation review tor sterile operations, Media Fill , Smoke Study , Monitoring and Qualification of Critical Area/ Utilities, training on aseptic practices/ techniques.
• Involve  in the failure investigations like batch, media fill, sterility test positive, OOS and

• incidents to support the SIT. Involve in the failure investigations like batch, media fill, sterility test positive, OOS and Incidents (which impacting the sterility assurance of the product) to support the SIT.

• Execution of unit operations like sterilization, CIP, SIP, lyophilization, VHP process, aseptic assembling etc. of the sterile/ core areas process.
• To ensure GLP activity in lab and compliance in Microbiology laboratory and GMP in the production area.
• Responsible for review and approval of Instrument/Equipment's calibration raw data and log books related to Microbiology.
• Responsible to perform the review/ verify/ checked by for MLT/BET/Sterility/bio burden/water/EM/cleaning validation/ method development or validation validation/protocol based studies and other miscellaneous activities.
• Responsible for participation / evaluation of Risk Assessment where ever applicable related to Microbiology and sterility assurance.
• Responsible for review /approval of ROA.
• Review and approve the LIMS masters.
• Review and approve visual inspection of media fill and handling exceptions in PAS/X.
• To review and approve the breakdown maintenance and impact assessment.
• Review and approve the temperature monitoring data of walk in chambers/incubators in SCS.
• Review and approval of protocols and reports related to Microbiology and sterility
  assurance.
• Review of Instrument/Equipment's audit trail related to Microbiology.
• Review of Instrument/Equipment’s audit trail related to Microbiology.
• To carry out any other job assigned by the Manager, Quality Assurance.

Educational qualification: A Bachelor’s degree in Pharmacy, Chemistry.
Minimum work experience: 3 to 10 years of experience in pharmaceutical manufacturing or a similar role

Skills & attributes:

• Investigation and approval of OOS, OOT and incidents.
• Investigation, root cause analysis, Corrective Action and Preventive action for incidents.

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/#!/