Dr Reddy’s Biotech & Microbiology Subject Matter Expert Position, Apply Online

Dr Reddy’s Biotech Position, Apply Online For SME Role

Subject Matter Expert (SME) – Biologics

Hyderabad, Telangana, India

Job Description

• Master’s degree in a relevant field such as Biotechnology.
• The Subject Matter Expert (SME) for Biologics process will serve as a key resource within the organization, providing technical expertise in the areas of 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, i.e., 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 programs, 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 processes, Cell culture, and Virus handling.
• 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 concerning 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. Microbiology and Biotechnology.

APPLY ONLINE HERE

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