Manager/Lead Associate, Quality Operations
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.
We have an opening for a Manager/Lead Associate, Quality Operations in our Princeton, NJ office.
This position will be responsible for:
- Leading the batch release group and for record reviewing and batch release of products from CMOs to the US This involves the review of Quality Control, manufacturing, packaging and Quality Assurance records.
- Oversee DRL Princeton External manufacturing Partners (Contract Manufacturing Organizations - CMOs), which manufacture, package or supply for distribution of Rx and SRx (drug and drug device combination products) and OTC products to Dr. Reddy’s North America business.
- Timely review and release of products from DRL Princeton CMOs and suggesting continuous improvements of systems at external partners (CMO’s and contract packaging organization, CPO’s) to assure compliance to CGMP’s that meet company goals and FDA expectations.
Education & Experience:
- B. S. in life science with zero to 3 years pharmaceutical industry experience or High school diploma with 3 to 5 years of progressive experience in a pharmaceutical manufacturing or quality environment.
- A total of 2+ years in a CFR 211 quality managementrole is preferred.
- Strong understanding of pharmaceutical manufacturing, packaging, and testing processes, and management of Quality Management Systems.
- Can detect batch review documentation or other gaps and can provide appropriate and timely corrections.
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.