Dr. Reddy's Laboratories Needs Quality Assurance Associate

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 : Quality Assurance Associate

Job Description:
This critical corporate Quality Assurance role will be responsible for oversight of Contract Packaging Organizations (CPO) which provides packaging products to Dr. Reddy’s North America Generic (NAG) business.

Responsibilities:

Manage Stability and Reserve sample programs while adhering to internal procedures.
Conduct batch record review and release, change control review and approval, process and analytical investigations, Annual Product Reviews, CAPA follow up etc. related to products manufactured at CPOs to ensure compliance.
Ensure products manufactured at CPO’s are produced in accordance with regulatory requirements, ANDA/NDA registration, and Corporate requirements
Manage effective communication with internal & external management groups to ensure compliance during quality audits
Coordinate interdepartmental activities with Project Management, Supply Chain Operations and other DRL sites.
Reviewing and providing final approval of master packaging instructions for contract packers.
Responsible to address issues and identify trends that help to ensure compliance, and development and implementation of process improvements
Be continually aware of current industry trends and regulatory agency interpretation of cGMP requirements.
Write and implement SOPs consistent with Corporate global systems regarding stability, retain program and CPOs
Track Quality metrics, identify risk areas and propose CAPAs to resolve Quality matters with external packaging partners.

Candidate Profile :

B.S. Degree in Scientific discipline (Chemistry, Pharmaceutics, Biology).
Minimum of 2+ years of experience of pharmaceutical Quality environment.
Strong understanding of pharmaceutical manufacturing, packaging and stability testing processes, and management of Quality Systems
Thorough understanding and familiarity with GMP Regulation, including 21 CFR 210 & 211, ICH Guidelines, FDA Guidance Documents and DEA Regulations.
Knowledge of pharmaceutical product life cycle management.
Experience with CAPA, Batch Review and Change Control Management is a plus.
Excellent communication (verbal &written), computer (MS Office – Excel, Word, PowerPoint, Access), and organization skills.
10% travel (domestic) to contract packaging & manufacturing organizations.

Additional Information:
Experience: 2+ Years
Education: Degree in Chemistry, Pharmaceutics, Biology
Location: Princeton, NJ
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Assurance Associate
Last Date: 30^th Dec., 2016