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Post for Manager, Development Quality Assurance @ Dr. Reddy's Laboratories | Bridgewater, NJ - USA

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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: Manager, Development Quality Assurance

Job Description:
Support development and implementation of appropriate quality systems for IND/NDA/ANDA development activities
Perform the review of development documents for IND, NDA, and ANDA submissions, including analytical method development/validation protocols and reports, product development reports, stability protocols and reports
Review batch records and associated documentation for release of batches for clinical and/or BA/BE studies
Together with Product Development, provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations
Perform qualification/due diligence audits of potential development and/or manufacturing partners

Candidate Profile:
B.S. or M.S. in scientific discipline, i.e. chemistry, biology, pharmaceutics or other life science
A minimum of 5 - 8 years in the pharmaceutical industry; previous Quality Assurance experience required
Experience in a research quality assurance setting required with a strong understanding of the pharmaceutical drug development process
Thorough understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents; familiarity with GLP and GCP regulations
Must be conversant with Pharmaceutical Formulation Development with fair understanding of QbD and its tools
Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail

Additional Information:
Bridgewater, NJ
Experience: 5-8 Years
Education: BS, MS - Chemistry, Biology, Pharmaceutics, Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code:
Last Date: 14th Nov., 2011

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