Remote QA Qualification & Validation Specialist

MANTU GROUP SA; Belgique; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of Mantu, seeks a QA/Qualification specialist to support qualification/validation in pharma and chemical industries. You will review documents, ensure cGMP compliance, and collaborate across engineering teams to implement validated systems.

Applicants should have pharma/chemical qualification experience, familiarity with Trackwise, Comet, TruVault, Kneat, and strong communication skills in English and Dutch.

Qualifications

• Experience in chemical/pharma with focus on qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Experience with manufacturing, laboratory, building, utility, IT, and automation systems in pharma/chemical industries.
• Familiarity with problem report and change request systems (e.g., Trackwise, Comet).
• Experience with document management systems (e.g., TruVault).
• Experience with test tools (e.g., Kneat).
• Ability to translate technical information for all levels of the organization.
• Ability to estimate urgency, criticality, and impact of decisions.

Responsibilities

• Support the QA Engineering department to ensure regulatory and procedural 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 with other groups for new or upgraded systems and processes.
• Provide advice and support for qualification/validation activities, ensuring cGMP aspects are respected.
• Address and follow up on deviations during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to the QA qualification/validation team.

Skills

QA & qualification

Regulatory compliance

cGMP knowledge

Validation experience

English & Dutch

Tools

Trackwise

Comet

TruVault

Kneat

Job description

Amaris Consulting, part of Mantu, seeks a QA/Qualification specialist to support qualification/validation in pharma and chemical industries. You will review documents, ensure cGMP compliance, and collaborate across engineering teams to implement validated systems.

Applicants should have pharma/chemical qualification experience, familiarity with Trackwise, Comet, TruVault, Kneat, and strong communication skills in English and Dutch.