AUFGABENBESCHREIBUNG: Act as Deputy QA Site Lead, supporting and substituting for the QA Lead in day-to-day operations and decision-making. Ensure compliance with GMP and ISO 9001 requirements across all QA activities at the Staad site. Lead, coordinate, and support internal and external audits, including customer audits and authority inspections. Manage QA oversight of production, laboratory, and supply chain operations in a CDMO environment. Drive qualification, validation, and compliance projects, including plant and equipment qualification. Collaborate with global QA and cross-site teams to align processes, implement best practices, and contribute to strategic initiatives. Provide guidance and training to QA team members and other departments on quality matters Identify, implement, and monitor continuous improvement initiatives within the QA system. Prepare, review, and approve QA documentation such as SOPs, CAPAs, deviations, and change controls. Serve as key contact for quality-related questions, risk assessments, and decisionmaking on complex issues.
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