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On-site

Job Type

Full Time

Job Description

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 Summary

  • You will be responsible for conducting analytical method validation activities at manufacturing sites.
  • You will be responsible for preparing method validation protocol, Method validation reports, and ensuring compliance with regulatory requirements for regulatory filings.
  • You will be responsible for conducting analytical method transfer activities at manufacturing sites and preparing method transfer reports
  • You will be responsible for conducting analytical method verification activities at manufacturing sites/IPDO for preparing method development reports,
  • You will be responsible for executing regular analytical tasks according to defined protocols, documenting data, and providing results for review and approval by the analytical expert or group leader
  • You will responsible for calibration/performance verification of analytical instruments and equipment as per master schedule.
  • You will be responsible to initiate and investigate CRN (Change Request Notice), Incidents,
  • You will be responsible for preparation of STPs (Standard Testing Procedures), Specifications, SOPs (Standard Operating Procedures), Protocols and Analytical test reports.
  • You will be responsible for Good laboratory practices, Safety practices, and Good documentation practices and ensure the cleanliness of the laboratory.
  • You will be responsible for laboratory standards and chemicals/solvents as per the laid down procedures
  • You will be responsible for systematically developing analytical methods for various tests mentioned in the specification to analyse product development batches.

Qualifications

Educational qualification:

  • Experience in Analytical method development and validation of injectable products.
  • Understanding on Abbreviated New Drug Application(ANDA) filing requirements.
  • Experience in Method Development

Behavioral

  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Strong Decision making skills.

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered

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