Development Quality Assurance Associate

  • Full-time
  • Job Family: Quality
  • Sub Job Family: Quality Assurance
  • Business unit: Biologics

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.

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Job Description

Job Summary

  • Involve in R&D Biologics Analytical data review (ELN) for samples and stability Data Review.
  • Analyst Qualification review and Authorization.
  • Review of Method development/Qualification Protocols, reports for Analytical methods.
  • Instrument Calibration review and authorization.
  • Hands on experience on analytical methods using different equipment’s/Instruments Ex: HPLC, UPLC, UV Spec, LC-MS, Nano DSC and etc.
  • Review of procedural documents such as SOPs / METs/ STPs / Specifications and Documents pertaining to PD in accordance with current QA requirements.
  • Review of Study protocols, stability protocols, reports and related documentation generated from the different studies of the products in PD.
  • Review and involve in Technology transfer activities.
  • Experience in internal audits.
  • Support in QMS Handling like review, closure of Incidents, CAPA, OOS and CC) etc.
  • Assuring compliance on the PD through Lab rounds.
  • Participate in PD LDM and update on Quality slides.
  • Equipment/Instrument Audit Trail review and support for PD.

Qualifications

Qualifications

Educational qualification: A Master degree in Biology, Pharmacy, Pharmaceutical Sciences, or a related field; Experience in Analytical R&D/DQA is advantageous

Minimum work experience: 3-7 years of experience in the Biopharmaceutical industry, with a focus on product development and quality management

Technical Skills

• Strong understanding of Biologics Analytical Development and data review.
• Experience in method development, qualification, validation, and technology transfer.
• Hands-on expertise in HPLC, UPLC, LC-MS, UV-Vis, and related analytical techniques.
• Knowledge of GMP, Data Integrity, QMS, and regulatory compliance.
• Experience in stability studies, technical documentation, and audit support.
• Proficient in instrument calibration, audit trail review, and compliance management.

Behavioral Skills

  • Analytical and critical thinking
  • Attention to detail
  • Quality and compliance mindset
  • Strong problem-solving and root cause analysis skills

Additional Information

About the Department

Biologics

Currently 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 Offered

At 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 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...

For more details, please visit our career website at https://careers.drreddys.com/#!/

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