Bio-Analytical Methods & Computerised Systems Validation Specialist (m/f)

REFERENZNUMMER:

306877/4

IHRE AUFGABEN:

-Validating bio-analytical methods and computerised systems that will be used for systems toxicology studies (methods involved are related to gene expression, gene sequencing, proteomics and in-vitro assays)
-Writing of analytical methods validation master plan and report
-Writing of analytical method validation test documents (including test protocols)
-Writing of computerised systems validation documentation, following GLP guidelines
-Reviewing validation documents
-Executing validation tests
-Training laboratory personnel on validation
-Plan and execute analytical method validations
-Plan and execute computerized systems validations

IHRE QUALIFIKATIONEN:

-Master degree in Science related field
-Profound experience in bio-analytical method validation and computerised systems validation in the pharmaceutical/medical device industry
-Very good knowledge of European Pharmacopoeia, GAMP 5, 21 CFR part 11, 21 CFR part 58 and OECD Series on Principles of GLP and Compliance Monitoring

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist