Dr Reddy’s Labs SME Role For MSc Biotech & Microbiology, Apply Online
Subject Matter Expert – Microbiology and Biologics
Hyderabad, Telangana, India
About the job
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with global operations. 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.
Job Description
- Master’s degree in a relevant field such as Microbiology or Biotechnology.
- Serve as the Subject Matter Expert (SME) for Microbiology and Biologics processes, providing technical expertise in microbiological testing, aseptic processing, and contamination control in manufacturing, 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 with microbiology lab instruments, including Vitek, KTA, and Rapid sterility methods.
- Experience in failure investigations related to Microbiology, Environmental Monitoring, Sterility Testing, Media Fill, Water, MLT, and Endotoxin Testing.
- Possess a strong understanding of the Environmental Monitoring program, Location Selection, and Area Classification.
- Familiarity with Pharmaceutical Regulatory guidance, including 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 Processes, Cell Culture, and Virus Handling.
- Exhibit strong communication, writing, and presentation skills.
- Experience conducting internal and external audits and handling regulatory inspections.
- Provide technical support and training on microbiology best practices in line with regulatory standards and expectations.
- Capable of evaluating identified discrepancies at sites and providing resolutions.
- Stay updated on industry trends, technologies, and regulatory changes related to microbiology and biological processes.
Qualifications: M.Sc. in Microbiology or Biotechnology.
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With greetings,
I am Tauqeer Zehra, I have done master’s degree in Biotechnology from Era University, Lucknow, presently I am working as a research Analyst at Era’s Lucknow medical College and Hospital. And have 1 year experience in this field also I have done my dissertation fro restorative neurology lab on the project of developing a model of ischemia using the 3 days old chick embryo. I am excited to join your company on the position of subject matter trainin, I will be great full If you will give me chance to serve in your organization.