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Senior QA Specialist Madrid Spain,  

Posted on : 26 January 2017

Project Description

Job Purpose: This position 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 drug product contract manufacturing organizations (CMOs) 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 implementedMain DutiesPerform external GMP and vendor qualification audits, risk assessments and write audit reports, and follow up on observation close-outsProvide quality support to technology transfer projects.Review GMP technical and validation reportsAnalytical methods.Laboratory and manufacturing equipment qualification where appropriate.Manufacturing and packaging processes.Computer/Automated systems involved in testing, manufacturing or materials control.Equipment cleaning procedures.Utilities with product contact.Lead Continuous Quality improvement initiativesProvides on-site guidance in the preparation of procedures and working instructionsAssists in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnelHelps support a permanent inspection readiness statusProvide QA support for regulatory filingsPerform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, Product Complaint System, Annual Product Quality Reviews, GMP Training, etc.Prepare documentation for Material Review Board presentation and meetingsSupport QA Management as requiredProvide GMP quality expertise, advice and/or assistance across the organization as required Candidate Requirements (competencies/work experiences):The successful candidate will have knowledge, skills & experience gained in a pharmaceutical industry. Ideally experience in Medical Devices and technology transferMinimum of 5 years  experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements including FDA.University degree in Chemistry, Pharmacy, Biology or equivalent.Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations,  cGMPs, regulatory issuesStrong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal organisational complexity and ambiguityFluid in the communications (both written and spoken) in EnglishExperience working with Contract Manufacturers preferred



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