Senior Quality Assurance Professional
hace 5 días
Company Overview
ALK Abello Spa is a global pharmaceutical company that has been helping people manage allergy for over 100 years. With a presence in over 80 countries and almost 3,000 employees worldwide, we are the leading provider of allergy treatments.
About the Role
We are currently seeking a highly skilled Senior QA Specialist to join our team in Madrid, Spain. As a member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality in our manufacturing processes and products.
About You
To be successful in this role, you will need to have a minimum of 5 years' experience in the pharmaceutical industry, with a strong background in quality systems, GMPs, and regulatory requirements. You will also need to possess excellent communication and leadership skills, as well as the ability to work effectively in a fast-paced environment.
Responsibilities
Your key responsibilities will include:
- Performing quality assurance activities associated with maintaining internal quality systems, including change control, deviations, CAPA, etc.
- Reviewing GMP technical and validation reports related to manufacturing and packaging processes, computer/automated systems, cleaning validation/equipment cleaning procedures, laboratory and manufacturing equipment qualification, facilities and utilities with product contact, analytical methods validation, and more.
- Providing quality support to technology transfer projects, on-site guidance in the preparation of procedures and working instructions, and assisting in providing resolution to GMP issues through identification of problem areas, refinement of systems, training, and coaching of relevant personnel.
- Helping support a permanent inspection readiness status, providing QA support for regulatory filings, preparing documentation for Material Review Board presentation and meetings, and supporting QA Management as required.
- Providing GMP quality expertise, advice, and/or assistance across the organization as required.
Benefits
We offer a competitive salary of €60,000 per annum, plus benefits including health insurance, pension plan, and generous annual leave. We also provide a remote working policy, allowing you to work from home part of your time, and access to our canteen where employees can have breakfast and lunch every day.
Estimated Salary: €60,000 - €70,000 per annum
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