In this role, you will be responsible for reviewing, approving, and overseeing validation and qualification activities within an international pharmaceutical and life sciences organization. You will work closely with colleagues from QA, Engineering, Production, and Technical Services and make a direct contribution to ensuring quality, safety, and regulatory compliance. For professionals with the right experience, this position offers a challenging environment with significant responsibility and impact.
As a QA Validation Specialist, you ensure that equipment, facilities, utilities, and processes comply with GMP guidelines, internal procedures, and applicable regulations.
Your responsibilities include:
- Reviewing and approving validation and qualification documentation (DQ, IQ, OQ, and PQ)
- Assessing and approving User Requirement Specifications (URS)
- Preparing, reviewing, and maintaining validation and qualification plans
- Performing and evaluating risk assessments for equipment, facilities, and utilities
- Approving FAT, SAT, commissioning, and validation reports
- Ensuring full traceability throughout validation projects
- Managing and reviewing lifecycle documentation for equipment and installations
- Conducting periodic reviews of validated GxP systems, equipment, and utilities
- Performing impact assessments for changes to equipment, facilities, and processes
- Supporting production and technical departments with validation activities
- Managing deviations, change controls, and CAPA processes
- Ensuring compliance with GMP, GxP, GDP, and quality requirements
- Providing advice on quality and compliance-related matters
- Identifying and implementing improvements within validation and quality systems
- Collaborating with QA, Engineering, Production, and Technical Services to ensure compliance
- Gross monthly salary between €4,500 and €7,000
- Temporary employment contract through Manpower
- Travel allowance of €0.23 per kilometer
- Pension accrual
- Full-time position of 40 hours per week
- Opportunity to work on high-level projects within the pharmaceutical and life sciences industry
- Significant responsibility within complex validation and compliance processes
- Collaboration with experienced specialists across multiple disciplines
- Room for professional and technical development
- Working environment focused on quality, knowledge sharing, and continuous improvement
