consultant qualification engineer

As a QA Engineer, you are responsible for ensuring quality and compliance within the asset management department. You will help mitigate risks through risk-based assessments during the design review process. The focus is on ensuring the quality of qualification activities and the management of system data. You will ensure that all documents and processes comply with applicable standards and procedures.

Responsibilities:

• Integrate quality standards to mitigate failure mode risks during risk-based assessments.

• Review and approve qualification documents, calibration and maintenance records, and certification master data.

• Review and approve notifications, change controls, and quality issues, including corrections and CAPAs.

• Participate in system introduction and change projects, ensuring quality and compliance aspects.

• Ensure that the qualification status is maintained during project execution.

• Prepare for inspections and audits and act as a point of contact for QA-related matters.

• Proactively contribute to improving qualification processes.

• Apply cGxP and ATMP standards and report incidents and deviations.

• Actively contribute to safety, health, and environmental standards.

Degree: Master in Engineering, Pharmacy, or equivalent.

Experience: At least 5 years of senior-level experience in the pharmaceutical industry.

Skills:

• Thorough knowledge of pharmaceutical legislation, cGMP regulations, and guidelines related to system qualification.

• Knowledge of the various systems used during the manufacturing process.

• Strong analytical skills, risk assessment, and communication skills.

• Collaboration, teamwork, and a proactive, innovative mindset.Languages: Fluent in Dutch and English (written and spoken).

This is a consultancy project with a competitive daily rate. We also offer the following benefits as part of your collaboration with Randstad Professionals:

• A market competitive salary according to PC200.

• Hospitalization insurance.

• Group insurance.

• 32 days of leave (20 legal + 12 extra).

• Meal vouchers.

• Training opportunities.

• Hybrid working.