Dr. Reddy’s Laboratories
Job Number : 5047189
Job Title : Sr.DQA Associate
Business Unit : Dr. Reddy’s Proprietary Products
Location : Princeton, NJ
At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Key Responsibilities :
- -Responsible for supporting the US-Development Quality Assurance team, for the Development activities at the North American based sites.
- -Review of Development Documents and process for IND, NDA, and ANDA, including Analytical methods, PDR -Implement the Development Quality System for Promius Pharmaceuticals. Develop, implement, track, review, approve elements of the Quality Management System, including, but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs, Product Complaints.
- -Interface with R&D and Project Management Team to conduct audits of US based CROs and contract development sites(CDSs);
- -Study, evaluate and approve the manufacturing and filing process of CROs; 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
- Educational Qualifications & Experience:
- -M.S/B.S Degree in scientific discipline (Chemistry, Pharmaceutics, Biology) -Approximate 5-7 years of experience in Pharmaceutical Quality Assurance or Quality Control. – Extensive knowledge with GMP, GCP and GLP requirements, specifically 21 CFR 210. 21 CFR 211 requirements.
- – Experience with dermatology products or medical devices is a plus.
- – Previous exposure to R&D quality systems and documentation procedures related to Development, Packaging and Testing. Travel of 15-20% including over-night stays through the US and Canada
- **We are a corporate office and not a doctor’s office. Unsolicited resumes sent to our office will not be considered for any open positions. Only interested parties that apply through our Career website will be considered for positions within Dr. Reddy’s Laboratories, Inc.**
- Equal Opportunity Employer: Minorities/Women/Veterans/Disabled
- An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
- Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit.
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Dr. Reddy’s Laboratories