Validation Engineering Services

Responsibilities

• You are responsible for development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
• You develop, implement and execute validation studies for cGMP-critical computerized systems.
• You generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized systems.
• You are responsible for the validation documentation through approval and implementation.
• You perform validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and company procedures.
• You ensure that the Validated Status of computerized systems is in compliance with cGMP at all times.
• You ensure projects (moderate scale & complexity) are managed in conjunction with all required company and cGMP regulatory standards.
• You provide input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
• You investigate/troubleshoot moderately complex validation problems.

Requirements

• Bachelor or master degree
• Experience with validation of software packages and computerized systems within pharmaceutical sector
• Capable of troubleshooting validation issues
• Full understanding of relevant quality and compliance regulations
• Strong communication skills
• Capable of working independently
• Able to execute project to plan
• Good knowledge English and Dutch