Qualification & Validation Engineer - Basel, Basel
vor 23 Stunden
Job summary
About ATP-CGPharm: For more than 30 years we have been supporting clients in Life Science Industry with services such as facility engineering commissioning qualification validation consulting quality assurance control environmental monitoring GxP Digital Solutions.
We contribute every day to ensuring pharmaceutical product quality patient safety strict compliance regulatory requirements by supporting continuous improvement manufacturing processes quality programs our clients.
Responsibilities
- Planning coordinating executing commissioning qualification validation CQV activities for process laboratory equipment cleanrooms HVAC systems GMP utilities cleaning validation computerized systems validation CSV.
- SUPPORTING FACILITY PROCESS ENGINEERING PROJECTS DESIGN QUALIFICATION THROUGH OPERATIONAL READINESS AUTHORING REVIEWING GMP LIFECYCLE DOCUMENTATION SUCH AS RISK ASSESSMENTS URS FS DS DQ FAT SAT IQ OQ PQ PROTOCOLS REPORTS VALIDATION MASTER PLANS PERFORMING OVERSEEING ON SITE QUALIFICATION VALIDATION TESTING SUPPORT DEV FEASIBILITY STUDIES CAPAs CHANGE CONTROL PROCESSES APPLY risk based strategies line current regulatory expectations EU FDA Annex data integrity guidelines MANAGING WORK PACKAGES SMALL PROJECT TEAMS ENSURING COMPLIANCE TIMELINES BUDGETS QUALITY STANDARDS CONTRIBUTION DIGITAL VALIDATION GXPDIGITAL SOLUTION INITIATIVES APPLICABLE.
Jobbeschreibung
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