QA Validation Specialist 3

Jefferson Wells; Maastricht; On-site; EUR 50,000 - 78,000; Full time

Benefits offered by this job

Travel allowance

Pension accrual

Temporary contract through Manpower

Job summary

Jefferson Wells in Maastricht is seeking a QA Validation Specialist to oversee validation activities in a GMP/GxP environment. You will review and approve DQ/IQ/OQ/PQ and URS, and drive validation plans with cross-functional teams.

The role requires a Bachelor’s or Master’s in a relevant field and at least five years of GMP/GxP experience, with strong English and quality-system knowledge. This is a full-time, on-site position with a temporary contract through Manpower.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or comparable field.
• Experience in GMP- or GxP-regulated environments is required.
• Experience with Qualification & Validation activities (DQ, IQ, OQ, PQ).
• Knowledge of cGMP, GDP, GAMP, and validation methodologies.
• Experience with deviations, CAPAs, and change control processes.

Responsibilities

• 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.

Skills

Validation

GxP compliance

Quality Assurance

Documentation

Change control

CAPA

GMP

Stakeholder management

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or comparable field

Job description

Would you like to play a key role within a GMP-regulated environment where quality, compliance, and validation are at the heart of every process? Do you have extensive experience with qualification and validation projects and thrive in an environment where accuracy and quality make the difference? Then this position as QA Validation Specialist in Maastricht could be the next step in your career.

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

What’s in it for you

• 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

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or a comparable field
• At least five years of experience within a GMP- or GxP-regulated environment
• Experience with Qualification & Validation activities (DQ, IQ, OQ, and PQ)
• Knowledge of cGMP, GDP, GAMP, and validation methodologies
• Experience with deviations, CAPAs, and change control processes
• Experience with equipment, facility, and utility validation
• Excellent command of the English language, both written and spoken
• Experience with quality management systems and compliance requirements within the pharmaceutical or life sciences industry

Preferably, you also have:

• Strong analytical and problem-solving skills
• Accurate and quality-focused working style
• Ability to work independently and take ownership
• Excellent communication skills
• Strong stakeholder management capabilities
• Strong organizational skills and the ability to manage multiple projects simultaneously
• Proactive and results-oriented mindset
• Experience with process optimization and continuous improvement initiatives
• Strong collaboration skills within multidisciplinary teams
• Ability to prioritize effectively in an environment with multiple ongoing projects

Are you the QA Validation Specialist ready for a new challenge in Maastricht? And would you like to apply your expertise in validation, compliance, and GMP within a professional organization where quality comes first? Then apply today.

For more information please contact Robin van Loon via [e-mail] or call 088 282-8128.