Job Description

Company DescriptionDr. 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 transparencyDr 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."Roles & Responsibilities

• You will be responsible for handling process support, Bio-similarity establishment, Analytical method development, Analytical Method Qualification
• You will be responsible for data, report review.
• You will evaluate change controls, deviation, and incident, investigations on (OOS) out of specification, (OOT) out of trend, and risk management.
• You will prepare, review the operational SOP's (Standard Operating Procedures) and reports.
• You will provide training on GMP (good manufacturing practices).
• You will respond to queries and questions regarding regulatory audits such as US FDA (Food and Drug Administration).

"QualificationsEducational QualificationPhD in life sciences with 5 years of industrial experience or a Master's degree in Life Sciences, Pharmaceutical Sciences, Chemical Engineering, or a related field with 10+ years of experienceMinimum Work Experience8 years of experience in pharmaceutical manufacturing operationsSkills & Attributes Technical Skills

• Chromatography/LCMS based method development, Method qualification, Method transfer
• Team management, mentorship for physicochemical tests and chromatography analysis
• Investigations for any deviation, OOS, OOT, stability trending
• Chromatography/LCMS data review and report writing and review
• Hands-on experience in regulatory audits
• Good understanding of documentation, GMP and good laboratories practice.

Behavioural Skills

• Capacity to provide training on GMP and other relevant areas.
• Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment.
• Efficiently manages time to meet production schedules and deadlines without compromising quality.
• Must have hands-on experience in sophisticated manufacturing machines and equipment.
• Effective communication and training skills for user departments and service providers.

"Additional InformationAbout the DepartmentBiologicsCurrently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon..." Benefits OfferedAt Dr. Reddy's, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards..." Our Work CultureAsk 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...For more details, please visit our career website at"

Dr. Reddy's Laboratories