External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.
Locations (3)
Allschwil, Basel-Country, Switzerland
Beerse, Antwerp, Belgium
Latina, Italy
Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
Identify, communicate and elevate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
Nice to have: Experience working with external manufacturers
Nice to have: Experience working on cross-functional project teams
Nice to have: Experience with product transfer, new product introduction, parenteral, and/or combination products