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QA Associate
Summary
Description
QA Associate – Ref NJ 13493
Main Responsibilities:
• Provide QA support and expertise on Computerized System Validation (CSV) activities in order to ensure compliance with GxP /21 CFR Part 11 regulations and internal standards
• Determine validation needs for new systems
• Provide QA support to the IT Department
• Review CSV and qualification documents
• Audit external suppliers and internal activities related to CSV and IT services
• Create and/or update related SOP’s
Required experience:
• Degree-educated in a related discipline
• Experience of CSV and system qualification
• Knowledge of GxP regulations, GAMP4 and 21 CFR Part 11
• Vendor / system auditing experience an advantage
• Experience in the pharmaceutical industry and regulated environments
• Fluency in English (knowledge of German and/or French an advantage)
Competitive salary and benefits, excellent working environment.
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