Description
On behalf of our client, an international pharmaceutical company, we are looking for a
CSV Specialist (m/f)
Reference: -en
Start: 11/14
Duration: 2 MM++
Place: in Basel region
Branch: Pharmazeutische Industrie
Your tasks:
- 50% support of validation of CRM/salesforce.com application
- 30% quality management/PMM alignment/ overview of quality process (on-boarding of resources, training, SOP creation/update coordinator for country roll-outs)
- 20% complaint management project supervision and collaboration
- Assessment of computer system regulatory risks against the requirements of GxP regulations
- Creating validation and qualification lifecycle deliverables
- Providing clear communication to project teams on validation approach and deliverables
- Providing regular project reporting
Your qualifications
- Knowledge in documenting CSV processes
- Experienced in reviewing test cases and executed test cases, requirements, and traceability
- Profound experience in validation planning and reporting
- Being familiar with agile (scrum) project methodology and validation of GxP relevant solutions
- Experienced in global roll-outs
- Experienced SOP technical writer skills
- Experience within an international and pharmaceutical environment
- Excellent communication skills
- Superb command of written and spoken English
Skills:
- Quality manager
Keywords: If you are interested please contact