Computer Systems Quality Manager

il y a 2 semaines


Gent, Belgique Argenx Temps plein

We are currently looking for a Computer Systems Quality Manager.

Key Accountabilities/Responsibilities:

- Develop the Computer Systems (CS) Quality strategy
- Manage the CS Quality audit program
- Create, review and manage the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports
- Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
- Lead and support GxP-determination and validation activities for global CS systems
- Evaluate, test, and validate software and CS services
- Support the creation of SOPs as author, reviewer, or expert
- Lead or collaborate on Quality projects to implement, change or upgrade CS systems and processes
- Support local CS QA as the Subject Matter Expert and provide global guidance
- Develop and implement QA problem reporting processes and systems
- Analyse deficiencies in service or performance and recommend product or service improvements to address problems
- Ensure computerised systems comply with all applicable GxP regulatory and the company’s requirements throughout the life cycle for the systems
- Designs and implements defect reduction programs

Desired Skills and Experience:

- Master’s degree in Sciences or Biological Engineering
- Proven experience in computer systems validation and time spent in quality assurance/compliance function
- Expert knowledge in Software Development Life Cycle (SDLC), IT Quality Management Systems, Computer Systems Validation, internal and external audits
- Good knowledge of CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11....)
- Experience with the implementation and maintenance of electronic Quality and Document Management system(s)
- Knowledge of relevant scientific discipline or equivalent through education and experience.
- Knowledge of Gxp regulatory requirements is preferres (i.e. GCP, GLP, GMP)
- Team player and good communication skills.
- Quality-minded individual who is accurate in execution and reporting
- Flexible attitude, capable of picking up the tasks that require attention.
- Proficiency with MS Office & SharePoint.
- Fluent in English - our working language.

**Offer**:

- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company.

LI-Onsite



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