Are you struggling to allocate the appropriate resources within your organization or is there a peak in workload due to project related compliance activities? We can help by providing experienced resources to temporarily expand your capacity to meet your need. Rescop offers various experts in different areas of expertise (quality validation, computer system validation, equipment validation, etc.) to support specific activities.

Examples of compliance management activities we can support:

  • Develop Validation Master Plan
  • Manage validation and qualification projects
  • Draw up Risk Assessments
  • Collect and document User Requirement Specifications
  • Develop Test Protocols and support execution
  • Develop System Management Plans

We also support our customers by (temporarely) fullfilling various roles. Therefore we offer various profilies of consultants.

Senior Validation Engineer

Competences:

  • Validate and maintain the validated state of automated 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 automated 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 writing 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 writing and verbal skills, English and Dutch
  • Pro-active
  • Strong customer focus
  • Flexibility/adaptability
  • Microsoft Office Proficient

 

Senior Auditor

Competences:

  • Perform internal/external automated system audits
  • Review compliance documentation
  • Set up/improve the auditing approach
  • Perform other quality assurance/control duties as required

Auditor

Competences:

  • Perform internal/external automated 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 writing 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 writing and verbal skills, English and Dutch
  • Pro-active
  • Strong customer focus
  • Microsoft Office Proficient