Remote QA Qualification & Validation Engineer

AMARIS GROUP SA; Geel; Híbrido; EUR 55.000 - 90.000; 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 Qualification & Validation Engineer to support QA activities across qualification and validation lifecycles for pharmaceutical equipment, facilities and processes. You will ensure cGMP compliance and collaborate with cross-functional teams to maintain a compliant GMP environment.

Requirements include proven QA qualification/validation experience in a regulated setting, strong cGMP knowledge, and familiarity with QA documentation and risk management.

Formación

• Experience in QA qualification and validation within a pharmaceutical or regulated industry.
• Strong knowledge of cGMP requirements and relevant pharmaceutical guidelines.
• Experience reviewing qualification and validation protocols, reports and quality documentation.
• Understanding of risk assessments, deviation management, change controls and CAPAs.
• Ability to prioritize activities and communicate decisions clearly.
• Familiarity with TrackWise, Kneat or similar systems is an advantage.

Responsabilidades

• Review and approve qualification and validation documentation, including URS, risk assessments, protocols, test plans, test scripts and final reports.
• Provide QA oversight and guidance for qualification and validation of equipment, facilities, utilities and processes.
• Ensure qualification and validation activities comply with cGMP and regulations.
• Review and follow up on deviations, change controls and CAPAs.
• Assess quality risks and ensure appropriate actions are implemented and documented.
• Support project teams throughout equipment and system lifecycle.

Conocimientos

QA/QV experience

cGMP knowledge

Documentation review

Risk assessment

Cross-functional teamwork

TrackWise or Kneat

Herramientas

TrackWise

Kneat

Descripción del empleo

Amaris Consulting is seeking a QA Qualification & Validation Engineer to support QA activities across qualification and validation lifecycles for pharmaceutical equipment, facilities and processes. You will ensure cGMP compliance and collaborate with cross-functional teams to maintain a compliant GMP environment.

Requirements include proven QA qualification/validation experience in a regulated setting, strong cGMP knowledge, and familiarity with QA documentation and risk management.