Job Purpose: Supports the development and maintenance of quality procedures, and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Novartis V&D Quality Manual requirements.
- Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products at the site comply with the requirements of the Novartis Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
- Maintain the quality systems related to Quality Assurance for in-process sampling and control, and all aspects of Shop floor QA for the USFCC facility, in compliance with cGMPs and the Novartis V&D Quality manual.
- Perform batch record review concurrent to completion of manufacturing operations, in real time.
- Support investigations and CAPAs providing QA review and approval.
- Assess and initiate deviations in real time.
- Perform routine quality audits in Manufacturing and QC laboratory environments, equipment, and procedures, with approximately 50-75% of the typical workday spent in the manufacturing suites.
- Participate as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams.
- Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
- Assist with the timely implementation of safety, security, industrial hygiene and ecology regulations in all parts of the site. Minimum requirements Requirements:
- Bachelor’s degree in the field of Science or Engineering or other appropriate field of study.
- Minimum of 3+ years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
- Sterile product manufacturing knowledge preferred. Biopharmaceutical experience a plus.
Novartis - 2 years ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...