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Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process...

• Maintain and continuously improve the Quality Management System and approvals.
• Act as the primary interface with civil and military aviation authorities, customers and certification bodies.
• Plan, lead and support internal, customer, supplier and regulatory audits.

• Preparation and visualization of quality- and process-related metrics, as well as data validation in databases (e.g., using Power BI)
• Support in the creation, revision, and updating of process and quality documents
• Coordination and tracking of review and approval processes

Shape quality from the start: Translate strategic ambitions into clear, actionable QA deliverables for corporate and new business development initiatives...

• Lead external sterilisation activities for active ingredients, excipients, and packaging materials.
• Prepare, review, and maintain sterilisation validation documentation.
• Support SIP and bulk product validation activities.
• Manage filter validation programs and ensure regulatory compliance.

• Lead quality oversight activities for assigned suppliers, CMOs.
• Experience with EU Cosmetic Regulation (EC) No. 1223/2009 and ISO 22716 (Cosmetic GMP), ISO 9001must have.
• Compliance with FDA, Health Canada is a plus.
• Support regulatory inspections, customer audits, and internal audits.

Manage key operational quality processes, including non-conformance reports (NCRs), quarantine, quality holds, field actions, line clearance and escalation to manufacturers....

Lead analytical activities including optimization, transfer, validation, and troubleshooting, ensuring methods are scientifically sound and fit-for-purpose...