Remote QA Qualification & Validation Specialist

Amaris Consulting | Part of Mantu

Geel

On-site

EUR 60,000 - 90,000

Full time

8 hours ago
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Benefits offered by this job

Health insurance
Remote work
Meal vouchers
Time savings account
Referral bonus

Job summary

Amaris Consulting, part of Mantu, is seeking a QA/Validation professional to support qualification activities across the lifecycle of pharmaceutical systems. You will review documents, ensure cGMP compliance, and collaborate with manufacturing, IT, and automation teams to implement robust validation strategies.

You will address deviations, communicate status to the QA team, and help translate technical requirements into accessible content for all levels of the organization.

Qualifications

  • Experience in the chemical/pharma industry with qualification/validation focus.
  • Knowledge of cGMP regulations and guidelines is required.
  • Experience with manufacturing, laboratory, building, utility, IT, and automation systems in pharma/chemical industry.
  • Familiarity with problem report and change request systems (Trackwise, Comet).
  • Experience with document management systems (TruVault) and test tools (Kneat).

Responsibilities

  • Support QA Engineering to ensure regulatory and procedural requirements are fulfilled.
  • Review and approve qualification/validation docs and quality records to maintain compliance.
  • Collaborate with engineering teams for new or upgraded systems and processes.
  • Provide advice/support for qualification/validation activities ensuring cGMP.
  • Address and follow up on deviations during qualification/validation activities.
  • Communicate status regarding quality, compliance, and planning to QA team.

Skills

Pharma industry experience
cGMP knowledge
Cross-functional collaboration
Communication skills
English and Dutch fluent
Documentation reading/writing

Tools

Trackwise
Comet
TruVault
Kneat

Job description

Amaris Consulting, part of Mantu, is seeking a QA/Validation professional to support qualification activities across the lifecycle of pharmaceutical systems. You will review documents, ensure cGMP compliance, and collaborate with manufacturing, IT, and automation teams to implement robust validation strategies.

You will address deviations, communicate status to the QA team, and help translate technical requirements into accessible content for all levels of the organization.

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