Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a strong commitment to accelerating access to affordable and innovative medicines. Established in 1984, Dr. Reddy’s has grown to over 24,000 employees and operates in 66 countries, with a mission to reach over 1.5 billion patients worldwide by 2030. The company prioritizes deep science, progressive people practices, and sustainability, aiming to build a future that is both purpose-driven and innovative.
Responsibilities in Job: Subject Matter Expert – Microbiology and Biologics
As a Subject Matter Expert (SME) for Microbiology and Biologics, your primary responsibilities will include:
- Providing technical expertise in microbiological testing and aseptic processing.
- Ensuring compliance with regulatory standards in contamination control and manufacturing processes.
- Validating microbiological testing methods, including endotoxins, sterility, and microbial limit testing (MLT).
- Conducting failure investigations related to microbiology, environmental monitoring, sterility testing, and endotoxin testing.
- Overseeing the environmental monitoring program and area classification.
- Resolving complex quality issues related to product testing.
- Conducting internal and external audits and managing regulatory inspections.
- Training staff on microbiology best practices in line with regulatory standards.
- Staying updated on industry trends, technologies, and regulatory changes.
Qualifications
To qualify for the Subject Matter Expert position, candidates must possess:
- A Master’s degree in Microbiology, Biotechnology, or a related field.
- Extensive knowledge of microbiological practices and regulatory guidelines, including Good Laboratory Practices (GLP), ICH, and 21 CFR parts 210 and 211.
- Hands-on experience with microbiology lab instruments, such as Vitek and rapid sterility methods.
- Strong communication, writing, and presentation skills.
- Experience in evaluating discrepancies and providing resolutions.
Skills
The ideal candidate will demonstrate the following skills:
- Expertise in microbiological testing and validation.
- Strong analytical and problem-solving abilities.
- Excellent organizational and project management skills.
- Ability to work collaboratively within a team and communicate effectively across departments.
- Commitment to continuous learning and professional development in microbiology and biologics.
