Job as Associate Director, Quality Assurance @ 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: Associate Director, Quality Assurance

Job Description:
This position will develop, lead, and mentor the QA team responsible for commercial QA support of Dr. Reddy’s North American Generics business
Provide guidance to the team in the development, implementation and management the quality systems, working with internal and external customers and partners, to ensure compliance with regulatory requirements
Manage the Quality System with a focus on continues improvement and responsible for ensuring compliance with CGMPs, FDA requirements, and internal SOPs
Ensure that Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements
Oversee the batch record review and release process to ensure timely release of product to the market
Provide quality oversight of all external partners, including contract manufacturers, packagers and testing labs providing product or services to Dr. Reddy’s
Develop and report metrics to senior management on the status of compliance; advise management of potential issues; ensure the implementation of appropriate corrective actions
Support in the preparation of all required FDA correspondence on compliance matters; serve as the host for regulatory (FDA, DEA, etc.) inspections
Perform GMP audits of vendors/ suppliers, including participating in due diligence audits as required

Candidate Profile:
B.S. or M.S. in scientific discipline, i.e. chemistry, biology, pharmaceutics or other life science
A minimum of 10 – 12 years of pharmaceutical experience, with at least 5 years in a management role in Quality Assurance
Extensive knowledge of pharmaceutical manufacturing, packaging and analytical testing for oral dosage products
Expert understanding of GMP requirements, 21 CFR 210 & 211; strong knowledge of FDA & ICH guidelines
Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
Demonstrated experience with hosting successful FDA inspections

Additional Information:
Location: Bridgewater, NJ
Experience: 10-12 Years
Education: BS, MS - Chemistry, Biology, Pharmaceutics, Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 2668438
Last Date: 5^th Nov., 2011