The following personnel can be hired to perform compliance tasks (for pricing, please contact us): Senior Validation Engineer
Competences: - Validate and maintain the validated state of computerized systems
- Set up/improve the overall validation approach
- Develop and maintain validation support (e.g. templates, typicals)
- Manage validation projects
- Advise/decide on required validation resources
- Participate in supplier assessment & selection
| Validation Engineer
Competences: - Validate and maintain the validated state of computerized systems
- Participate in supplier assessment & selection
- Develop and maintain validation support (e.g. templates, typicals)
- Improve the validation approach
| Personnel profile: - Higher level education or Academic degree in computer science
- In-depth knowledge of regulations and quality standards
- At least 3 years experience with validation
- Project management experience
- Experienced user of GAMP
- Excellent written and verbal skills, English and Dutch
- Leadership qualities
- Strong customer focus
- Flexibility/adaptability
- Pro-active
- Microsoft Office Proficient
| Personnel profile: - Higher level education or Academic degree in computer science
- Knowledge of regulations and quality standards
- Experience with validation
- Project experience
- Familiar with GAMP
- Good written and verbal skills, English and Dutch
- Pro-active
- Strong customer focus
- Flexibility/adaptability
- Microsoft Office Proficient
| Senior Auditor
Competences: - Perform internal/external computerized system audits
- Review compliance documentation
- Set up/improve the auditing approach
- Perform other quality assurance/control duties as required
| Auditor
Competences: - Perform internal/external computerized system audits
- Review compliance documentation
- Perform other quality assurance/control duties as required
| Personnel profile: - Higher level education or Academic degree in computer science
- In-depth knowledge of regulations and quality standards
- At least 3 years auditing experience
- Experience with validation
- CISA certified
- Experienced user of GAMP
- Flexibility/adaptability
- Excellent written and verbal skills, English and Dutch
- Pro-active
- Strong customer focus
- Microsoft Office Proficient
| Personnel profile: - Higher level education or Academic degree in computer science
- Knowledge of regulations and quality standards
- Experience with auditing
- Experience with validation
- Flexibility/adaptability
- CISA certified
- Familiar with GAMP
- Good written and verbal skills, English and Dutch
- Pro-active
- Strong customer focus
- Microsoft Office Proficient
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