Manager/Lead Associate, Quality Investigations
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.
We have an opening for a Manager/Lead Associate, Quality Investigations in our Princeton, NJ office.
This position will be responsible for below:
- Ensures all Dr Reddy’s NAG partners comply with GMP’s.
- Provides Quality 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, escalates and approves critical laboratory and Operations investigations with potential to affect product availability.
- Ensures data integrity and Data review controls and improvement efforts across North America region.
- Trends, escalates issues to ensure method and product robustness based on monitoring of trend data.
- Reviews Analytical method and process development, enhancements and validation/verification, transfer related documents and 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 of GMP 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.
Equal Opportunity Employer: Minorities/Women/Veterans/Disabled
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.