Team Member - Quality Control ( Analytical Method Validations/Transfers) at Dr Reddy's Laboratories Limited

, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

21 Sep, 26

Salary

0.0

Posted On

23 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Validation, Analytical Method Transfer, Method Verification, HPLC, UPLC, GC, LC-MS, Empower Software, LIMS, DocHUB, OOS Investigations, Deviation Handling, ICH Guidelines, cGMP, Protocol Preparation, Report Writing

Industry

Pharmaceutical Manufacturing

Description

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. " Job Description Job Purpose TM QC (Method Validation & Transfer) - API & Finished product Should able handle troubleshooting of analytical methods during validation, along with preparation of protocols and reports, and provide guidance to the other colleagues. Should experience in preparation of validation protocols and reports. Team member for analytical method validations/transfers to handle product. · Should have knowledge and hands‑on experience in Analytical Method Transfer (AMT), Method Validation, and Method Verification. · Should have sound knowledge and experience in investigations and report preparation for Deviations and OOS. · Should have knowledge and hands‑on experience in protocol and report preparation in DocHUB for AMT, AMV, and Method Verification. · Should have real‑time working knowledge of LIMS and EMPOWER applications, including chromatographic data processing. · Should have hands‑on experience in handling HPLC, GC, and UPLC systems. · Should be able to independently plan and execute AMT, AMV, and Method Verification activities. · Should have hands‑on experience in handling LC‑MS. Qualifications Educational Qualification M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / Chemistry or equivalent Experience 10-12 years of relevant experience in Quality Control or Analytical R&D within the pharmaceutical industry Proven hands‑on experience in: Analytical Method Transfer (AMT) Analytical Method Validation (AMV) Method Verification Exposure to regulated environments (USFDA, EMA, or other global regulatory agencies) is preferred Mandatory Technical Skills Hands‑on experience with HPLC, UPLC, GC, and LC‑MS Strong working knowledge of EMPOWER software for chromatographic data handling Practical experience with LIMS Hands‑on expertise in DocHUB for protocol and report preparation Sound understanding of ICH guidelines, cGMP requirements, and investigation processes Additional Information 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 https://careers.drreddys.com/#!/" Job Family: Quality Sub Job Family: Quality Control Preferred type of working: On-Premise Years of Experience: 12 - 20 Business unit: GMO

Responsibilities

Responsible for planning and executing analytical method validations, transfers, and verifications for API and finished products. This includes troubleshooting analytical methods, preparing protocols and reports, and managing investigations for deviations and OOS.