Senior Quality Assurance Expert

hace 13 horas


Madrid, Madrid, España Alk Nordic AS A tiempo completo

Job Overview:
As a Senior Quality Assurance Expert, you will be responsible for ensuring the performance of manufacturing, packaging operations, and product quality conforms to established cGMPs. This position requires a high level of involvement in continuous improvement of the quality assurance philosophy and practice.

Key Responsibilities:
• 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
• Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel

Requirements:
• 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, 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

Estimated Salary:
$120,000 - $180,000 per annum



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