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5 Months Ago
Manager / Lead Associate, Quality Investigations
$124k-155k (estimate)
Full Time | Wholesale 7 Months Ago
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Dr. Reddy's Laboratories is Hiring a Manager / Lead Associate, Quality Investigations Near Princeton, NJ

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Diversity, Equity & InclusionAt Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. 
Purpose:
We are seeking an exceptional investigator to join us as Lead Associate, Quality Investigations in our Princeton, NJ office, this role will report to Lead Quality Systems.Responsibility:
  • Ensureall Dr Reddy’s NAG partnercomply with GMP’s.
  • ProvideQuality support related to Analytical and Operations issues, Laboratory and Operations investigations, Product Specifications, Analytical Method Validation, Process Validation, Method and process Transfer and major Change Controls for commercial and products under development are reviewed by QA in a timely manner.
  • Reviews, supports, escalateand approves critical laboratory and Operationsinvestigations with potential to affect product availability.
  • Ensuredata integrity and Data review controls and improvement efforts across North America region.
  • Trends, escalateissues to ensure method and product robustness based on monitoring of trend data. 
  • Reviews Analytical method and process development, enhancements and validation/verification, transfer related documentsand raw data generated at DRL internal and contract 
  • Support Regional internal and external laboratory and operations Audits, supplier quality management.
Education & Experience: 
  • Bachelor’s Degree (or its U.S. equivalent) in Life Sciences, Pharmaceutical Sciences or a closely related field with 8 years of experience in a pharmaceutical and/or biotech.
  • Strong knowledge in In Pharmaceutical manufacturing and/or Laboratory techniques; especially Chromatography(HPLC, GC), Dissolution and compendia test procedures
  • Experience in handling Analytical Method Validation, Method Transfer activities Experience in handling Laboratory and Operations investigations, Out of Specifications/Out of Trends and CAPAs
  • Strong understanding of pharmaceutical process and/or method development and testing processes, and familiarity with Quality Management Systems.
  • Familiarity with Data Integrity and Data review controls 
  • Thorough understanding ofGMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents
  • Must have prior experience in working with cross-functional teams 
  • Excellent communication (verbal and written), strong analytical and investigative, organizational and time management skills; Strong attention to detail. 
  • Excellent negotiation and influencing skills required.

Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

COVID-19 Vaccination

Getting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy’s encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future.

Equal Opportunity Employer:

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Wholesale

SALARY

$124k-155k (estimate)

POST DATE

10/06/2023

EXPIRATION DATE

05/29/2024

WEBSITE

drreddys.com

HEADQUARTERS

PRINCETON, NJ

SIZE

200 - 500

FOUNDED

1984

CEO

MARC KIKUCHI

REVENUE

$200M - $500M

INDUSTRY

Wholesale

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About Dr. Reddy's Laboratories

Dr. Reddys Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products Dr. Reddys offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddys operates in markets across the ...globe. Our major markets include USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com For more information, log on to: www.drreddys.com More
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