CSV Specialist (m/f)

REFERENZNUMMER:

254182/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Quality manager