CSV Specialist - Innovative Company

Our client are a human-sized company, having people on board from diverse cultural and professional backgrounds, image which mirrors the array of projects and clients they work with.
This implies you will have a lot of networking opportunities, will be working on some innovative and daring projects and implicitly make your profile more marketable which leads to securing future roles a lot more easily.

Ensures Computerized System are validated and that all external and internal validation requirements are met
Ensures that validated Computerized Systems remain validated throughout their life cycle

The Role

• Acts as QA authority in the assigned area of responsibility
• Drive adherence to computer quality & compliance policies and guidelines
• Reviews and improves Computerized System Validation (CSV) documents and ensures adherence to internal and external guidelines
• Is involved in the creation and approval of major documents like validation plans and reports.
• Ensure QA requirements for IT systems are covered.
• Share expertise and knowledge to provide input to project teams and global functions
• Support, communicate and follow-up on key Quality issues related to Computer Compliance.
• Participate as subject matter expert for Compliance in Team meetings where necessary to ensure adequate representation of Computer Compliance issues for discussion and escalation

Requirements

• Strong knowledge in IT quality assurance and computer compliance demonstrated through management of projects in this area
• SAP knowledge
• Significant experience in Computer System Validation is mandatory.
• Expert knowledge of appropriate regulations including CFR, Eudralex, and industry publications such as GAMP, ICH, PIC/S.
• Good knowledge in Good Manufacturing Practices and Quality Management System (QMS).
• Fluent English & French, Dutch would be an advantage (written and spoken)

Call me, Alex Manea, at NonStop Recruitment now for a confidential conversation. Contact me on A.Manea@nonstop-recruitment.com or : +41 435 080 817 , please send your CV in word format OR if this does not sound like the opportunity for you, but you are a professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, USA, Romania, Luxembourg and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover