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Subject Matter Expert
hace 1 mes
Job Summary:
Dr. Reddy's Laboratories Ltd. is seeking a highly skilled Subject Matter Expert - Microbiology and Biologics Process to join our team. As a key resource within the organization, you will provide technical expertise in microbiological testing and aseptic processing, contamination control in the manufacturing process in accordance with regulatory standards.
Key Responsibilities:
- Provide technical expertise in microbiological testing and aseptic processing, contamination control in the manufacturing process in accordance with regulatory standards.
- Demonstrate a strong understanding of microbiological testing method validation, including Endotoxins, Sterility, MLT, Identification program, and PET as per relevant regulatory standards.
- Hands-on experience in the handling of microbiology lab instruments, such as Vitek, KTA, Rapid sterility method.
- Experience in failure investigations related to Microbiology, Environmental monitoring, Sterility testing, Media fill, Water, MLT, and Endotoxin testing.
- Strong understanding of Environmental monitoring program, Location selection, and Area classification.
- Familiarity with Pharmaceutical Regulatory guidance related to microbiology Good laboratory practices, ICH, 21 CFR part 210 and 211, and USP general chapters.
- Ability to resolve complex Quality issues related to Product testing and specific concerns.
- Strong understanding of Biological process, cell culture, Virus handling.
- Exhibit strong communication, writing, and presentation skills.
- Exposure to conducting internal and external audits and handling Regulatory inspections.
- Provide technical support and training on microbiology best practices w.r.t. Regulatory standards and expectations.
- Capable of evaluating identified discrepancies at sites and providing resolution.
- Stay updated on industry trends, technologies, and regulatory changes related to microbiology and biological process.
Requirements:
- M.Sc. Microbiology and Biotechnology.
About Us:
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. The 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:
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, joining and relocation support, family support (Maternity and Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
