SME - Sterile & Microbiology

• Audits: Plan and execute the internal audits; Identify & escalate risks to businesses; ensure adequacy of CAPA; To support the site QA during regulatory audits. This includes providing systems so as to ensure compliance with respective to cGMP.
• Provide technical inputs for Preparation and review of Global procedures in consultation with site teams.
• Regulatory Intelligence & compliance-Analyse external 483s/WLs perform the gap assessments by utilizing the regulatory intelligence from various sources such as regulatory guidances regulatory inspectional observations and best industrial practices to identify gap between the regulatory requirements and governing the company operations practices and process.
• To provide technical expertise in the areas of microbiological testing and aseptic processing contamination control in the manufacturing process in accordance with regulatory standard.
• Demonstrate a strong understanding of microbiological testing method validation includes Endotoxins Sterility MLT Identification program and PET as per relevant regulatory standards.
• Hands-on experience in the handling of microbiology lab instrument i.e. Vitek KTA Rapid sterility method.
• Experience in failure investigations related to the Microbiology Environmental monitoring Sterility testing Media fill Water MLT and Endotoxin testing.
• Person shall have strong understanding w.r.t. Environmental monitoring program Location selection and Area classification.
• Shall be familiar with Pharmaceutical Regulatory guidance related to the microbiology Good laboratory practices ICH 21 CFR part 210 and 211 and USP general chapters.
• Should be able to resolve the complex Quality issues related to Product testing and specific concerns.
• Exhibit strong communication writing and presentation skills.
• Stay updated on industry trends technologies and regulatory changes related to the microbiology and biological process.

Qualifications :

(Mircobiology/ Biotechnology) with 15 years of experience in aseptic Manufacturing process.

Additional Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 1150 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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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

Remote Work :

No

Employment Type :

Full-time