Senior QA Specialist

Job description

Are you looking for an exciting opportunity to join an international pharmaceutical company? In ALK, we are on a mission to improve the lives of people living with allergies, and we are seeking a person responsible for a wide range of Quality Assurance activities, providing quality oversight for Contract Manufacturing Operations (CMOs) involved in the manufacturing and packaging of ALK products. You will ensure that all activities are executed in compliance with company standards and applicable regulatory requirements. As a trusted quality partner, you will actively contribute to the continuous improvement of our Quality Management System, driving best practices and helping to strengthen a culture of quality, compliance, and operational excellence across the organization. Key responsibilities: · Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, APQR, etc. · Review GMP technical and validation reports o Manufacturing and packaging processes. o Cleaning Validation/Equipment cleaning procedures. o Laboratory and manufacturing equipment o Facilities and Utilities with product contact. · 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 · Provide QA support for regulatory submissions · 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 Candidate 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. • Fluency in both written and spoken English and Spanish is essential. • Thorough knowledge in Oral solids forms and technology transfer projects. • Knowledge in sterile product regulations is valuable. • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, GMPs, regulatory issues, data integrity requirements. • Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can navigate organisational complexity and ambiguity. • Availability to travel approximately 30% of the time.