Quality Assurance Specialist

QA Qualification Specialist 

About the role

We are seeking an experienced QA Qualification Specialist to support a Quality Assurance Engineering department in a regulated manufacturing environment.
You will ensure that qualification activities meet regulatory and procedural requirements across the full lifecycle of manufacturing systems — from concept and project phase through operation and retirement.

This is a compliance-focused role working closely with engineering and operational teams to safeguard cGMP standards and quality requirements.

Key responsibilities

Quality & Compliance Oversight

• Review and approve qualification and quality documentation, including:

  • SOPs

  • User Requirement Specifications (URS)

  • Impact and risk assessments

  • Test plans and test scripts

  • Change controls

  • CAPAs

• Ensure compliance with applicable regulations, guidelines, and internal quality standards

• Safeguard cGMP principles during implementation and operation of systems

Project Support

• Participate in engineering project teams introducing new or upgraded systems and processes

• Provide QA guidance during preparation and execution of qualification activities

• Assess urgency, criticality, and compliance impact of decisions

Deviations & Lifecycle Management

• Manage and follow up deviations occurring during qualification activities

• Communicate quality and compliance status to stakeholders

• Support the full lifecycle of systems: concept ? implementation ? operational ? retirement

Candidate profile

Experience & knowledge

• Experience in pharmaceutical and/or chemical manufacturing environments

• Hands-on experience with equipment qualification

• Strong understanding of cGMP regulations and guidelines

• Ability to translate technical information into clear quality guidance

• Comfortable managing multiple projects simultaneously

• Able to work independently and within cross-functional teams

• Strong communication and stakeholder engagement skills

Systems & tools (preferred)

• Manufacturing systems within regulated industries

• Quality systems (e.g. TrackWise, COMET)

• Document management systems (e.g. TruVault)

• Digital validation tools (e.g. Kneat)

Languages

• Fluent English (written and spoken)

• Fluent Dutch (written and spoken)

Experience level

• Senior / experienced specialist (typically 5+ years relevant experience)

If you are a QA professional who enjoys working closely with engineering teams while safeguarding compliance in a regulated production environment, we would be happy to discuss the opportunity with you.