The Quality Manager will be able to represent the site quality organization with expertise in Data Integrity. Maintain currency with U.S. and European regulations related to Data Integrity. Perform Data Integrity risk assessment of manufacturing and laboratory systems and evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps.
Experience:
- Relevant quality assurance experience (comparable to 10+ years) including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
- 5+ years working in a GMP regulated environment
- 3+ years of experience in a quality role
- 3+ years of experience in a computer systems validation or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job.
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
- Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint )
Education:
- Bachelor’s degree (or equivalent) required in a relevant scientific discipline
About us -VIE HIRE We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.
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If this role is not a fit for you, and you're actively looking to be considered for work; please email us your resume: HireMe@VIEHIRE.com