Randstad Professional, a leading HR services provider specializing in placing highly qualified professionals, is looking for a QA Qualification/Validation Contractor for our valued client.
As a QA Qualification/Validation Contractor, you will be responsible for ensuring that all regulatory and procedural requirements related to Qualification/Validation are met throughout the entire lifecycle of systems and processes. This includes the concept, project, operational, and retirement phases.
Your key responsibilities will be to:
* Review and approve qualification/validation documents and quality records, such as SOPs, user requirements, risk analyses, test plans, test scripts, change controls, and CAPAs, to ensure compliance with regulations and guidelines.
* Collaborate with engineering teams and other departments on the introduction of new or upgraded systems and processes, providing expert advice and support to safeguard cGMP aspects.
* Address and follow up on deviations that occur during the execution of qualification/validation activities.
* Communicate the status of quality, compliance, and project planning to the QA qualification/validation team.
Multiple profiles are needed for this project, with opportunities in the following areas:
* Manufacturing Systems Qualification
* Laboratory Systems Qualification
* Facility and Utility Systems Qualification
* IT/Automation systems Computer System Validation
Experience: Significant experience in the chemical and/or pharmaceutical industry with a focus on qualification/validation. Skills:
* Strong knowledge of cGMP regulations and guidelines.
* The ability to translate complex technical information for various organizational levels.
* Excellent judgment to correctly estimate the urgency, criticality, and impact of decisions.
* Proven ability to multi-task and manage a variety of projects simultaneously.
* Capacity to work both independently and as part of a cross-functional team.
* Good communication skills.
* Knowledge of systems like Manufacturing, Lab, Building, Utility, IT, and Automation systems used in the pharmaceutical or chemical industry.
* Familiarity with problem report, change request, and document management systems (e.g., Trackwise, Comet, TruVault) and test tools (e.g., Kneat) is a plus.
* Languages: Fluent in English and Dutch (written and spoken).
We will offer you:
A market competitive salary according to PC200, Hospitalization insurance, Group insurance, 32 days of leave (20 legal + 12 extra), Meal vouchers, Training opportunities, FIP (=Flexible Income Plan)