Lead Associate, Quality Investigations
Posted on Apr 6, 2021 by Dr. Reddy's Laboratories Ltd
We have an opening for a 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.