Quality Assurance Professional

hace 3 semanas


Madrid, Madrid, España Alk Abello Spa A tiempo completo

Job Description:

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We are seeking a highly skilled Senior QA Specialist to join our team at Alk Abello Spa. As a key member of our quality assurance function, you will play a critical role in ensuring the performance of manufacturing, packaging operations and product quality conforms to established cGMPs.

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Main Responsibilities:

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  • Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.">
  • Review GMP technical and validation reports: Manufacturing and packaging processes, Computer/Automated systems involved in testing, manufacturing or materials control, Cleaning Validation/Equipment cleaning procedures, Laboratory and manufacturing equipment qualification, Facilities and Utilities with product contact, Analytical methods validation">
  • Provide quality support to technology transfer projects, Provide on-site guidance in the preparation of procedures and working instructions, Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel">
  • Help 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">
  • Identify and implement opportunities for process improvements to increase efficiency and reduce costs, Collaborate with cross-functional teams to achieve business objectives, Develop and maintain effective relationships with colleagues and external partners">
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Requirements:

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  • 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: Fluent in communications (both written and spoken) in English">
  • Thorough knowledge in sterile products regulation, Knowledge in oral solids forms and technology transfer projects is valuable, Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and 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 organizational complexity and ambiguity">
  • Ideal candidates will have experience in Medical Devices">
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About Us:

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Alk Abello Spa has over 100 years of experience and nearly 3,000 employees around the world. We apply our scientific knowledge and expertise to help people manage their allergies and improve their quality of life.

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Benefits:

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  • We offer a competitive salary, Benefits include health insurance, pension plan, annual bonuses, and flexible working hours">
  • Opportunities for professional development and growth within the company">
  • A dynamic and collaborative work environment with diverse projects and challenges">
  • Access to modern facilities and resources to support your work">
  • We also have remote working policy that allows you to work from home part of your time">
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Location:

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This position is located at ALK's site in Madrid, which is in the business area of Ciudad Lineal, very close to the center of Madrid. The manufacturing center is located at Calle Miguel Fleta 19 while the Business Support area is in an annex building located in the Avalon Business Park.

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Estimated Salary:

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$60,000 - $80,000 per year



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