Copy Of Subject Matter Expert

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations 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 We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparency Dr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization 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 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 Shall have strong understanding on Biological process cell culture Virus handling Exhibit strong communication writing and presentation skills Exposure for conducting the internal and external audits and handling the Regulatory inspections Provide technical support and training on the microbiology best practices w r to Regulatory standards and expectation Capable of evaluating identified discrepancies at sites and providing resolution Stay updated on industry trends technologies and regulatory changes related to the microbiology and biological process Qualifications M Sc Microbiology and Biotechnology Additional Information Global Manufacturing Organisation GMO 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 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 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 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 Reddy s why they come to work every day and they ll say because Good Health Can t 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 we re 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 We believe in the power of unity where diverse skills a common purpose and shared values spark magic Who we areWe accelerate access to affordable and innovative medicines becauseGood Health Can t Wait Watch