QA Qualification & Validation Specialist

AMARIS GROUP SA; Geel; Presencial; EUR 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Descripción de la vacante

Amaris Consulting is seeking a QA Validation professional to support qualification/validation across life sciences systems in a fast-growing, multinational environment. You will help ensure cGMP compliance and maintain quality records throughout the lifecycle of projects.

Key responsibilities include reviewing validation documents, supporting deviation management, and collaborating with cross-functional teams for new and upgraded systems.

Formación

• Experience in chemical/pharma with qualification/validation focus.
• Knowledge of cGMP regulations and guidelines.
• Experience with manufacturing, laboratory, building/utilities IT and automation systems.
• Familiarity with issue tracking and change request systems (TrackWise, Comet).
• Experience with document management systems (TruVault).
• Experience with test tools (Kneat).
• Ability to translate technical information for all levels of the organization.
• Ability to estimate urgency, criticality, and impact of decisions related to the function.
• Ability to multi-task and manage multiple projects.
• Ability to work independently and within cross-functional teams.
• Fluent in English and Dutch.

Responsabilidades

• Support the QA Engineering department to ensure all qualification/validation regulatory and procedural requirements are fulfilled throughout the system lifecycle.
• Review and approve qualification/validation documents and quality records (SOPs, user requirements, impact/risk analyses, test plans, test scripts, change controls, CAPAs, etc.) to maintain compliance with regulations, guidelines, and company policies.
• Participate in engineering teams and collaborate with other groups for the introduction of new or upgraded systems and processes.
• Provide advice and support for the preparation of qualification/validation activities, ensuring cGMP aspects are respected.
• Address and follow up on deviations occurring during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to the QA qualification/validation team members.

Conocimientos

cGMP knowledge

QA validation

Documentation skills

TrackWise

Kneat

TruVault

Cross-functional collaboration

Communication skills

Multi-tasking

Independent work

English and Dutch fluency

Herramientas

TrackWise

Kneat

TruVault

Comet

Descripción del empleo

Amaris Consulting is seeking a QA Validation professional to support qualification/validation across life sciences systems in a fast-growing, multinational environment. You will help ensure cGMP compliance and maintain quality records throughout the lifecycle of projects.

Key responsibilities include reviewing validation documents, supporting deviation management, and collaborating with cross-functional teams for new and upgraded systems.