Job Description

Company DescriptionDr. 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 transparencyDr 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 for the Quality Assurance team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology
Roles & Responsibilities
Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test).Responsible for review and Approval of Microbiological testing data/ Master data in LIMS.Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to Microbiology.Responsible to carry out the investigations related to Microbiology and timely closure of the same within the defined timeline.Review and approval of SOPs, protocols and reports related to Microbiology.Ensuring the compliance of Audit observations related to Microbiology.To review trends as applicable and to recommend any changes for the better control of the system.To review and approve STPs, Specifications, preparation of record of analysis and analytical test report.To ensure cGLP activity in lab and compliance in Microbiology laboratory.Responsible for the Monthly audit trail review of Instrument /Equipment's related to microbiology.Responsible for the review and approval of Analytical method validation with respect to Microbiology.Monitoring of Media Fill/ Process Simulation and review of media fill protocols and reports.QualificationsEducational qualification: A Master degree in Microbiology, or a related field.Minimum work experience: 3 to 5 years of experience in Pharmaceutical Microbiology / Quality assurance or a similar roleSkills & attributes:Technical Skills

• Knowledge of microbiology and aseptic practices and Aseptic Process simulation activities and disinfectant validation and handling of Microbiological Cultures.
• Skilled in review of Microbiological data, EM, water and compressed air trends.
• Review of EM and water trends, trends, Handling of Microbiological Culture.

Behavioural Skills

• Attention to detail in performing line clearance, verification, and record reviews.
• Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities.
• Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
• Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
• Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

Additional InformationAbout 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/#!/

Dr. Reddy's Laboratories