OFERTA DE TRABAJO Auditor/a de Calidad- Industria Farmacéutica

Auditor/a de Calidad- Industria Farmacéutica. Nombre de la empresa: SPRING PROFESSIOAL, ubicada en Madrid y alrededores. From Spring Professional and our Life Sciences department, we are looking for a Site Auditor. This person will lead the GMP and Regulatory audit activities (Regulatory, Internal, Partner and Supplier). This position is instrumental in supporting the site efforts to ensure ongoing compliance. Main duties: Organize and perform Quality Assurance/Regulatory Compliance audits at the site, contract manufacturers and supplier sites in a manner that will provide for clear identification of deviations from cGMPs and other regulatory requirements. Consult with Director of QA concerning audit observations and corrective actions, compliance deviations and policy matters. Conduct independent audits (System and Walk-through). Provide guidance and recommendations as necessary to ensure that audited groups implement corrective actions. Evaluate the acceptability of the contractor/vendor/supplier from a Quality Assurance/Regulatory Compliance point of view and make recommendations to senior management. Participate as part of the site inspection time in external audits (Regulatory, Corporate QA and Partner). Management of Quality Agreement with contract manufacturers and suppliers. Support Continuous Quality improvement initiatives. Provide GMP quality expertise, advice and/or assistance across the organization as required. 35% travelling. Education: University degree in Chemistry, Pharmacy, Biology or equivalent. Work Experience: Minimum of 5 years’ experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements including FDA. Competencies & knowledge: Must have strong GMP (EU & FDA regulations) knowledge. Must have technical knowledge of Finished Pharmaceuticals/Biologics manufacturing and Laboratory Operations. Ideally experience in Medical Devices. Strong interpersonal and leadership skills. Fluid in the communications (both written and spoken) in English. What do we offer? Indefinite contract with a leading pharmaceutical company specialized in allergen. Competitive pay band and social benefits. Interesados entrar en el siguiente enlace: 

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