CSV Specialist
Vor 3 Tagen
We are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.
Key ResponsibilitiesAs a CSV Consultant, you will be responsible for:
- Managing and executing CSV projects for customers in the life science sector
- Evaluating and creating gap analyses, CSV documents, and data governance
- Ensuring compliance with relevant regulations, with a focus on data integrity
- Executing validations on ERP, MES, IT, monitoring, and automation systems, as well as LIMS
- Creating and processing risk analyses, validation plans, SOPs, changes, deviations, CAPAs, V-plans, and V-reports
- Commissioning computerized systems and conducting data integrity gap analyses
- Submitting recommendations and optimizations to ensure GMP compliance
To be successful in this role, you will need:
- An academic education in a scientific, technical, or business administration field
- At least 5 years of professional experience in GxP compliance
- Extensive knowledge of GxP compliance or computer system validation
- Sound knowledge of regulatory requirements, including GxP, Annex 11, Annex 15, 21 CFR Part 11, FDA/EU guidelines, Swiss Medic, and GAMP 5
- Experience as a project manager for customer projects
- Independent and reliable working style
- Strong conceptual and analytical skills, with the ability to develop sustainable and pragmatic solutions
- Fluency in written and spoken German and English
- Appropriate mobility and flexibility
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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