Your new company

Your new role

• Create, review, and approve qualification protocols—including vendor protocols—executed protocol summary reports, and Requirements Traceability Matrices (RTM) for equipment, utilities, facilities, and computerised systems.
• Develop, review, and approve Validation Project Plans and Validation Summary Reports.
• Plan, execute, review, and approve IQ, OQ, and PQ activities, including management of deviations and exceptional conditions.
• Witness and oversee vendor commissioning and qualification activities as required.
• Support and maintain the periodic review program for validated systems.
• Perform and approve periodic evaluations to confirm the ongoing validated state of systems.
• Collaborate with cross-functional teams and external vendors/contractors.
• Ensure compliance with GMP/GxP standards and regulatory expectations (FDA, EMA).
• Actively participate in multidisciplinary teams as a CQV team member or CQV lead.
• Define CQV strategies and approaches during planning, design, and execution phases.
• Collaborate closely with Manufacturing, Engineering, Quality, and external vendors to ensure alignment on validation activities.

What you'll need to succeed

• Minimum 5 years of experience in CQV within a GMP-regulated environment (10+ years preferred).
• Proven experience in validation of equipment, utilities, and facilities.
• Hands-on experience drafting and executing IQ/OQ/PQ documents.
• Strong understanding of GMP/GxP requirements.
• Familiarity with FDA and EMA regulatory expectations
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• High attention to detail and documentation accuracy.
• Ability to work independently and within cross-functional teams

What you'll get in return

Hays Detachering | This is a project that will start with a contract for 12 months through Hays. An extension to 6 months may be possible. In this position, you will get a competitive salary (starting from €89,000), holiday pay and your travel expenses are covered.

What you need to do now