11/11/2019
Validation Lead (m/f)
For our Validation as a Service Team, we are looking for an experienced and ambitious Validation Lead (m/f) in Basel region.
Background
The VaaS (Validation as a Service) service ensures that the CSV tasks are performed providing the necessary deliverables such as Validation Plan or –Report within a project or the lifecycle of a system within defined time and quality.
General information
• Start date: ASAP
• Work location: Kaiseraugst, Rotkreuz
• Work load: 100%
• Remote: possible
Tasks and Responsibilities
a) Main tasks:
• Plan, lead and report Validation Activities in small to big IT projects
• Ensure that regulatory and pharmaceutical specifications are adhered to additional tasks
b) Responsibilities:
• Provide regulatory requirements for a computerized system in all stages of the system delivery process (Define, Design, Build, Test, Deploy)
• Participate in system risk and functional risk assessment activities and provide validation subject matter expertise for identification of risks
• Determine testing strategy, requirements and acceptance criteria
• Provide training CSV related to project teams
• Verify system installation and assure configuration control is in place
• Participate in the test management and assessment of deviations
• Ensure transfer activities meet predefined acceptance criteria
• Confirm test results, deviations, issue resolutions and deviations from plan are documented
• Confirm traceability and test coverage
• Summarize and document all validation activities, including data migration and/or data loading, prior to release a computerized system for use
• Ensure any outstanding transition activities are executed in compliance with validation plan
Experience / Skills
• Degree in business/IT technical/scientific area or comparable education/experience
• 5+ years experience in computerized system validation, instrument or software validation or related area within a regulated industry
• Experience with GxP / CSV / e-compliance requirements in an IT context
• Experience with GAMP 5, ITIL and Risk Management
• SAP ERP knowledge is an advantage
• Good communication skills, very good written and spoken English and German (both mandatory)
Nice to haves
• Former Pharma experience (ideally having worked together with an IT quality function in the past)
• HP ALM
• SharePoint User
• Leadership capabilities
* * *
We are able to offer you diversified responsibilities in a professional and dynamic international team, performance-matched benefits, and a friendly work environment.
Have we awakend your interest? Then we look forward to receiving your online application with your full CV.
For any further questions please do not hesitate to contact us
Contact: Mirco Lucarella
Managing Partner
Mobile: +41 61 222 23 33
[email protected]