By joining Dr. Reddy's, 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.
Title: Associate, External Quality Operations
Dr. Reddy's Laboratories, Inc.: Princeton, NJ
Responsible for monitoring product quality and compliance in line with cGMP requirements at the Contract Manufacturing Organizations (CMO's) and Contract Packaging Operations (CPO's). Review and release of products mfd/packaged by external partners in line with Dr.Reddy's requirements.
* Ensure products manufactured / packaged for Dr. Reddy's at external Partners are produced in accordance with regulatory requirements, ANDA/NDA registrations, applicable Quality Agreements and in compliance with Dr. Reddy's procedures. * Review and approval of specifications, test procedures, master batch records, validation protocols and master labels etc. * Conduct batch manufacturing and analytical records review and release * Support to continuous improvement by tracking and trending Quality metrics; * Support/conduct quality review meetings with CMOs to compile the observations * Review and approve change controls associated with products and processes pertaining to Dr. Reddy's; Determine appropriate follow up actions to implement the change, in colloboration with internal experts and ensure successful implementation. * Actively identify, report and address deviations in products / batches manufactured for Dr. Reddy's * Evaluate adequacy of CAPAs proposed and ensure implementation * Conduct post marketing actions such as Product complaints investigations, Annual Product Reviews, Stability management etc. in a timely and effective manner * Comply and adhere to the Internal Code of Business Conduct and Ethics (COBE) and all Company Policies and Procedures.
* B.S. or M.S. in a Chemistry, Biology, or other life science; 5+ years of experience in a pharmaceutical quality environment * Strong understanding of pharmaceutical manufacturing, packaging and testing processes * Thorough understanding and familiarity with GMP regulations, including 21 CFR part 210, 211 and 820 * Experience working with diverse complex dosage forms is desirable. * Strong work knowledge of Microsoft Office (Excel and Word, PowerPoint etc.) required. Experience on ERP and QMS systems is a plus * Excellent verbal and written communication; strong attention to detail * Ability to work in a dynamic, fast paced, flexible work environment; * Ability to collaborate in a cross functional teams to achieve functional objectives * Ability to learn complex processes and adapt quickly to change * Ability to travel up to 15%
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.