CSV Consultant
We are looking for motivated colleagues to join our team.
What you will do
Management and operational execution of CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.
Evaluation and creation of gap analyses, CSV documents and data governance
Ensuring compliance with the relevant regulations with a focus on data integrity
Execution of validations on ERP, MES, IT, monitoring and automation systems and LIMS in the life science sector
Creation and processing of :
Risk analyses according to FMEA
Validation plans & SOPs
Changes & Deviations & CAPA's
V-plans and V-reports
Validation test protocols for various validation phases
Execution of :
Commissioning of various computerized systems
Data integrity gap analysis
Submitting recommendations and optimizations to ensure GMP compliance
A further component is the conceptual further development of various services within the area of competence, training and coaching in the area of compliance and CSV as well as the involvement and guidance of our consultants in projects.
Requirements
What you bring with you
Academic education in a scientific, technical or business administration field
At least 5 years of professional experience in the field of GxP compliance
Extensive knowledge of GxP compliance or computer system validation
Sound knowledge of regulatory requirements (GxP, Annex 11, Annex 15, 21 CFR Part 11, FDA / EU guidelines, Swiss Medic, GAMP 5)
Experience as a project manager for customer projects
Independent and reliable way of working
You take a methodical approach and have strong conceptual and analytical skills, as well as a quick grasp of new ideas
Development of sustainable and pragmatic solutions together with the customer
Fluency in written and spoken German and English
You have the appropriate mobility and flexibility
CSV Consultant
A further component is the conceptual further development of various services within the area of competence, training and coaching in the area of compliance and CSV as well as the involvement and guidance of our consultants in projects. Management and operational execution of CSV projects for custom...
CSV Consultant
A further component is the conceptual further development of various services within the area of competence, training and coaching in the area of compliance and CSV as well as the involvement and guidance of our consultants in projects. Management and operational execution of CSV projects for custom...
CSV Consultant
A further component is the conceptual further development of various services within the area of competence, training and coaching in the area of compliance and CSV as well as the involvement and guidance of our consultants in projects. Management and operational execution of CSV projects for custom...
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