Job as a Senior QA Specialist at Dr. Reddy's Laboratories | Bridgewater, NJ - USA

Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

Post: Senior QA Specialist

Job Description:
Responsible for supporting the US - Development Quality Assurance team on activities at the US based sites
Review of Development Documents and processes for INDs, NDAs and ANDAs, including analytical methods and Product Development Reports
Interface with Business Development and Project Management Team to conduct audits of CROs and contract development sites (CDSs) for US based sites
Study, evaluate and approve the manufacturing and filing process of CROs and CDSs, conduct re-qualification audits for those CROs/CDSs based at US
Facilitate for Performing Risk assessment and monitoring of proposed mitigation plans
Implementation of QbD tools wherever feasible in product development process

Candidate Profile:
M.S./B.S. Degree in scientific discipline (Chemistry, Pharmaceutics, Biology)
Approximately 5-7 years of experience in the Pharmaceutical Quality Assurance
Extensive knowledge on GMP, GCP and GLP requirements, specifically 21 CFR 210 and 211 requirements
Previous exposure to R&D quality systems and documentation procedures related to Development, Packaging and Testing

Additional Information:
Location: Bridgewater, NJ
Experience: 5-7 Years
Education: BS, MS-Chemistry, Pharmaceutics, Biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 2583448
Last Date: 21^st Sept., 2011