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 all analytical reports and raw and electronic data from PD team, including: raw materials, finished products, stability study samples, packaging materials, in process materials, cleaning analysis, and equipment calibration. Inform PD Manager and QA when tests are not within specified limits to take appropriate actions.
Essential Duties And Responsibilities
- Ensure that analytical data generated meets company standards and regulatory requirements.
- Perform review of all tests results, raw data including electronic data generated in support of testing of raw materials, in-process, finished product and stability samples including, assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, etc., and tests according to the in-house monographs and USP in a regulated laboratory environment.
- Check all laboratory notebooks and associated documents for correctness of raw data and verifies all reagents, standards and equipment used are within the acceptance range.
- Review raw data for its audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release.
- Review all validation and method optimization reports.
- Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
- Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
- Analyze and interpret results in written and oral format.
- Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Provide the required support during the regulatory and internal audits.
- Perform additional tasks as assigned by QA supervisor.
Qualifications
Education & Experience
- Bachelor’s degree in Chemistry or related field
- 5+ years related experience in pharmaceutical analysis and QA data review
- Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including: Familiarity with testing and lab practices associated with HPLC/UPLC, GC, FT-IR, Empower, etc. is required.
- Understanding of SOPs, ICH, USP/NF procedures and requirements.
- Previous cGMP/regulatory experience is preferred
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.
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