IT Validation Lead

Category: Digital & IT

Location:Ballerup, Capital Region of Denmark, DK

• Drive and execute validation and qualification strategy, including making a Validation plan, Validation report, Design Review, Test strategy and execution etc.

• Conduct diverse assessments including Supplier, IT risk, IT requirements risk, and functional and data integrity assessments

• Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel to create and update system documentation and instructions as necessary

• Ensuring that systems are following relevant internal and external regulatory requirements, including finding solutions to compliance gaps identified in audits and inspections.

• Foster strong relationships with colleagues and stakeholders through effective communication, including workshops and risk assessments.
  
  

• B.Sc. within Engineering, Chemistry, Pharmacy, IT or similar.

• Extensive and proven experience in one of the two: Computer System Validation (CSV) or manufacturing/production experience with recognized GMP certificate/qualification.

• Strong knowledge of IT Gx P validation, preferably in a regulated industry such as pharma or healthcare. Relevant certifications such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC

• Have experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.

• You should have excellent communication skills and be able to effectively communicate with stakeholders, team members, and management. You should be able to articulate compliance requirements and validation strategy and provide guidance on best practices.