Quality Assurance Specialist – Oxford Global Resources – Leiden

New position for a Quality Assurance Specialist within a large international pharmaceutical concern in Leiden! Job Description For one of our clients within the pharmaceutical industry we are looking for a Quality Assurance Specialist with expertise in batch record review, deviations, CAPA plans and a proven track record in an FDA or similar regulated environment. In this role you are responsible for the communication with external sites, traveling is common for up to 25% of your time. Strong interpersonal and written/oral communication skills are essential within this role as well as the ability to build connections with stakeholders and manage across cultures. Responsibilities Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets. Evaluate batch manufacturing records, deviations, and associated CAPA plans and identify issues which may impact the quality of the product or the compliance to marketing authorizations. Independently resolve minor issues Consult with the account manager as needed for resolution of major issues Ensure that all relevant QA related concerns at external manufacturing sites are raised to expected management. Ensure manufacturing operations external manufacturing sites are executed in a compliant manner Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution. Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production) Able to connect easily, team worker, able to manage across cultures Requirements BSc or MSc with relevant QA experience; A minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred A minimum of 5 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production) Able to build connections with stakeholders, and manage across cultures Strong interpersonal and written/oral communication skills Proficient in applying process excellence tools and methodologies Amount of travel 25% English mandatory, other languages are a benefit Valid Dutch work permit is a must, candidates not in possession of a work permit will not receive a response; Benefits Contract: 1 year via Oxford, realistic long- term perspective; Salary: €4631- €5700 gross monthly based on a full-time position; Holidays: 25; Working hours: full-time, 32 hours possible; remote work is possible for this position Region: Leiden; Vacancy number: 21755;

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