Remote QA Qualification & Validation Specialist

Mantu; Geel; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a QA Qualification/Validation specialist to support regulatory compliance across the system lifecycle. You will review qualification documents, ensure cGMP adherence, and collaborate with engineering and other groups to implement new or upgraded systems.

You will communicate status on quality, compliance, and planning to the QA team, manage deviations, and help prepare qualification activities in line with regulatory guidelines.

Qualifications

• Experience in chemical/pharma industry with qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Experience with manufacturing, laboratory, building, utility, IT, and automation systems in pharma/chemical industry.

Responsibilities

• Support QA Engineering to ensure qualification/validation requirements are fulfilled throughout the system lifecycle.
• Review and approve qualification/validation documents and quality records to maintain compliance.
• Participate in engineering teams and collaborate on new or upgraded systems and processes.
• Advise on qualification activities ensuring cGMP aspects are respected.
• Address deviations during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to the QA team.

Skills

GMP awareness

Regulatory compliance

Project management

Cross-functional teamwork

Analytical thinking

Tools

Trackwise

Comet

TruVault

Kneat

Job description

Amaris Consulting is seeking a QA Qualification/Validation specialist to support regulatory compliance across the system lifecycle. You will review qualification documents, ensure cGMP adherence, and collaborate with engineering and other groups to implement new or upgraded systems.

You will communicate status on quality, compliance, and planning to the QA team, manage deviations, and help prepare qualification activities in line with regulatory guidelines.