Senior Qa Specialist

hace 3 semanas

Zaragoza, España Alk-Abello A tiempo completo

.The position Reports to: Quality Support Manager Are you passionate about working in a global pharmaceutical company that helps people living with allergy? Are you motivated to make improvements, leading to better economy, quality and social responsibility? Are you perceived as a structured and constructive person with excellent collaboration skills? As a Senior QA Specialist (High proficiency in English) , you will provide support for and be directly responsible for a range of Quality Assurance functions. This position will contribute to ensure that performance of manufacturing, packaging operations and product quality conforms to established cGMPs to ensure lasting customer satisfaction. This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented. Fields of responsibility Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc. Review GMP technical and validation reports. Provide quality support to technology transfer projects. Provides on-site guidance in the preparation of procedures and working instructions. Assists in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel. Helps support a permanent inspection readiness status. Provide QA support for regulatory filings. Prepare documentation for Material Review Board presentation and meetings. Support QA Management as required. Provide GMP quality expertise, advice and/or assistance across the organization as required. Your qualifications Minimum of 5 years' experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements. University degree in Chemistry, Pharmacy, Biology or equivalent. Essential skill: Fluid in the communications (both written and spoken) in English. Thorough knowledge in sterile products regulation. Oral solids forms and technology transfer projects knowledge is valuable. Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation. Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal with organisational complexity and ambiguity. Ideally experience in Medical Devices. The company By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience and almost 3,000 employees around the world, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life

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