IT Validation Lead

Category: Digital & IT

Location:Ballerup, Capital Region of Denmark, DK

• Proven and extensive experience within validation of IT systems, preferably from the pharma industry (Gx P), or other regulated industries
• Experience working with large scale projects and validation, preferably in an agile manner
• Good communication and facilitation skills
• Fluent in spoken and written English

• Execution of validation and quality control activities: Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, reporting, and ensuring that these are executed effectively. Helping develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing
• Conducting assessments such as IT risk assessment, Supplier Assessment etc., and facilitating the workshops for these activities: Ensuring validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in cooperation with the system managers and IT responsible when needed
• Participating in audits and inspections and then finding solutions to identified compliance gaps: Ensuring that systems follow relevant internal and external regulatory requirements. Ensuring the data integrity and security requirements of IT system have been met and may work with systems include GDPR/Confidentiality data

• Supporting development teams in creation and maintenance of test plans, test scripts and user acceptance tests: Managing the execution of test plans. Supporting overall validation approaches in different teams/Projects in the LABS department, and suggest improvements