Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities
Role Summary
Review manufacturing batch records, analytical reports and related documentation to ensure that products meet release requirements, and to identify areas of opportunity and quality improvements. Inform QA when documentation and processes are not within compliance to take appropriate actions.
Essential Duties And Responsibilities
- Review of executed batch records and all related documentation for manufacturing activities in accordance with good documentation practices (GDP), product specifications, process parameters and regulatory requirements.
- Communicate effectively with cross functional departments to ensure on time delivery of corrections, QA review and disposition responsibilities.
- Compile and review all applicable documentation for batch review and release, keep track and oversee status of batches to ensure all QA batch disposition deadlines are met.
- Review of analytical reports to ensure that products, material, components and intermediates meet company standards and regulatory requirements.
- Review of tests results, generated in support of testing of raw materials, in-process, finished product and stability samples including, but not limited to, assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to the in-house monographs and USP and other compendia in a regulated laboratory environment.
- Review of environmental monitoring data, microbiology and cleaning testing results.
- Review of Quality events, incidents and deviations related to manufacturing processes, and to Laboratory testing, OOS, OOT, and OOE investigations.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Provide the required support during regulatory and internal audits.
- Keep track of data and records review indicators for internal quality metrics and annual product review.
- Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, create and revise relevant SOPs.
- Perform additional tasks as assigned by the QA supervisor.
Qualifications
Education & Experience
- Bachelor’s degree in Life Sciences discipline.
- 4+ years’ experience within the pharmaceutical, biologic, medical device or regulated industry.
- 2+ years’ experience in a Quality Assurance/Quality Control or Manufacturing function.
- 1+ year batch record and analytical data review experience required.
- Previous experience using analytical instrumentation, software, and tests performed in the lab, including: HPLC, GC, Dissolution, Raw Materials, etc. is preferred.
- Understanding of SOPs, STPs, USP/NF, GLP, ALCOA and data integrity procedures, guidelines and requirements.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin . No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.
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