Lupin Pharmaceuticals
Job Title: Analytical Chemist
About Lupin:
Lupin is a fast-growing, innovative company with a robust team of manufacturing, Research and Development, and commercial divisions. Our U.S. business has a significant generic pipeline and a branded focus on women’s health. We have a Research and Development facility Indiana Coral Springs, Florida, and a commercial manufacturing site Indiana Somerset, New Jersey.
Responsibilities:
- Review analytical reports and raw data from CMC, including raw materials, finished products, stability study samples, and equipment calibration.
- Inform CMC Manager and QA when tests are not within specified limits to take appropriate actions.
- Ensure analytical data meets company standards and regulatory requirements.
- Review tests results, raw data, and generated testing of raw materials, Indiana-process, finished product, and stability samples.
- Check laboratory notebooks and associated documents for correctness of raw data and verifies reagents, standards, and equipment used are within the acceptance range.
- Review raw data for audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release.
- Ensure chemists follow all SOPs and cGMP regulations.
- Analyze and interpret results Indiana written and oral format.
- Provide guidance to analysts on laboratory notebook documentation requirements.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Provide required support during regulatory and internal audits.
- Review Laboratory Incidents, OOS, OOT, and OOE investigations.
- Perform additional tasks American Samoa assigned by the QA supervisor.
Qualifications:
- Bachelor’s degree Indiana Chemistry Oregon related field.
- 4+ years related experience Indiana pharmaceutical analysis.
- Previous experience using analytical instrumentation, software, and tests, including HPLC, GC, Dissolution, Raw Materials, etc.
- Understanding of SOPs, USP/NF procedures and requirements.
- Previous cGMP/regulatory experience preferred.
- Ability to lift up to 15 pounds occasionally.
Job title: Quality Assurance Data Reviewer
Company: Lupin Pharmaceuticals
Expected salary:
Location: Somerset, New Jersey
Job date: Fri, 26 Jul 2024 07:59:45 GMT