Computer Systems Quality Manager

MindCapture
Oost-Vlaanderen, Belgium
about 1 month ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Languages
English
Job source

Tech stack

Document Management Systems Microsoft Office Systems Development Life Cycle Microsoft SharePoint Verification and Validation (Software) Computerised Systems Information Technology GXP

Job description

We are looking for a Computer Systems Quality Manager to strengthen our partner’s team. In this role, you will ensure that computerised systems are designed, validated and maintained in accordance with strict regulatory and internal quality requirements.

Quality strategy

Develop and maintain the Computer Systems Quality strategy in line with regulatory requirements and business objectives.

Validation deliverables

Create, review and manage validation documents including risk assessments, validation plans, qualification plans and final reports.

Audit management

Lead the Computer Systems Quality audit program, support regulatory inspections and assess risks related to observations.

System compliance

Ensure GxP determination, validation and lifecycle management of global computerised systems in line with GMP and industry standards.

Software validation

Evaluate, test and validate software and services while ensuring compliance with internal and external requirements.

SOP management

Author, review and maintain SOPs while acting as Subject Matter Expert for local and global QA teams.

Continuous improvement

Analyse service or performance deficiencies, recommend solutions and lead projects that improve compliance and efficiency., This opportunity is offered directly through MindCapture. As a consultant, you will become part of our dedicated network of experts in Life sciences and Cleantech. You will work on projects that truly matter, bringing your expertise to clients who are shaping a healthier and more sustainable future.

Requirements

  • Master’s degree in Sciences or Biological Engineering
  • Proven experience in computer systems validation within a quality assurance or compliance function
  • Strong expertise in SDLC, IT Quality Management Systems, CSV and audits
  • In-depth knowledge of GMP and regulations for automated systems, including GAMP, Eudralex Vol 4 Annex 11 and 21 CFR Part 11
  • Experience with electronic Quality and Document Management Systems
  • Quality-driven, detail-oriented and accurate in execution and reporting
  • Team player with strong communication skills
  • Proficiency in MS Office and SharePoint
  • Fluent in English

Benefits & conditions

Pulled from the full job description

  • Company car
  • Eco vouchers, At MindCapture, you are not just taking on a new job. You are joining a community that values who you are and what you bring to the table.

You can count on:

  • A competitive salary with a complete benefits package including 32 vacation days, meal and eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car with fuel or charging card or mobility budget.
  • Real ownership in your role where your voice matters and your input is heard.
  • Personal growth support with coaching, tailored training and clear career paths.
  • Purpose-driven projects with leading clients, shaping a healthier and cleaner world.
  • A warm and open company culture built on teamwork, trust and connection.

About the company

  • Final interview & welcome - In a final chat with our team, we close the process and warmly welcome you to MindCapture, guiding you towards a smooth start with us or at the client site.

Apply for this position

This job is hosted externally. Click below to view the full posting and apply.

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