Beschreibung
NextLink Solutions need to hire a Computerized System Validation (CSV)/QA Validation Consultant - German & English Speaking for a crucial and very complex project, where all your business analyst skills will be tested.
This very exciting and critical project is for a global and highly sought after a pharma company in Ludwigshafen, Germany
Required Skills:-
- Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry.
- Sound knowledge on regulatory compliance. One or more of the following areas: CAPA, 21 CFR Part 11, GAMP, GMP, GLP, GCP, GVP, GxP, IQ/OQ/PQ and Computer Systems Validation (CSV).
- Thorough knowledge of business and process analysis functions in Lab Informatics area.
- Experience working on applications related to Electronic Laboratory Notebook (ELN), CDS, LIMS, SDMS etc. related to Discovery and Drug Product Development areas.
- Create and execute validation test scripts and document test results in accordance with standards (Manually or in HP Quality Center).
- Review and evaluate validation assessments for application systems/projects.
Interviews are now taking place, so call Samuel immediately for a confidential chat.