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• German Language skills (both verbal and reading/writing) is a MUST
• 3+ years of specific experience working in reputed pharmaceutical company
• 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.
• Initiate, drive and support validation efforts and deliverables for systems used for Discovery/Instruments/Clinical/Pre-clinical with minimal oversight
• Advise customer technical organization in validation specific questions
• Review and evaluate validation assessments for application systems/projects
• Ensures that validation project documentation is in compliance with company and legal policies and procedures
• Prior Experience with validation of Discovery/Instruments/Clinical systems preferred
• Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)
• File validation documentation, following Quality Assurance Library guidelines
• Ensures that project documentation is in compliance with AbbVie’s policies and procedures
• Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager