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Pharmaceutical Quality Assurance Specialist with Expertise
hace 2 meses
About Us
ALK, a global pharmaceutical company, has been helping people manage allergies for 100 years. With a presence in over 80 countries and almost 3,000 employees worldwide, we strive to provide innovative solutions for those affected by allergies.
Our Mission
We aim to make allergy management surprisingly simple by collecting trusted information and latest solutions in one place. Our expertise spans a wide range of products, services, and resources that offer a fast-track to a more balanced life.
Job Description
As a Senior QA Specialist, you will play a crucial role in ensuring the performance of manufacturing, packaging operations, and product quality conforms to established cGMPs. This position requires high proficiency in English and involves supporting technology transfer projects, providing quality support to regulatory filings, and preparing documentation for Material Review Board presentations.
Responsibilities
- Maintain internal Quality Systems, including Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports.
- Provide quality support to technology transfer projects.
- Offer on-site guidance in preparation of procedures and working instructions.
- Assist in resolving GMP issues through problem identification, system refinement, training, and coaching.
- Support permanent inspection readiness status.
- Provide QA support for regulatory filings.
- Prepare documentation for Material Review Board meetings.
Requirements
To succeed in this role, you must have at least 5 years of experience in the pharmaceutical/biotech industry, a thorough knowledge of quality systems, GMP, and regulatory requirements. You should hold a university degree in Chemistry, Pharmacy, Biology, or equivalent. Essential skills include fluency in English, both written and spoken, and expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
Benefits
ALK offers a competitive salary ranging from €60,000 to €80,000 per annum, depending on your experience and qualifications. You will also enjoy benefits such as remote working options, a canteen where employees can have breakfast and lunch, and access to public transportation. Ideally, you should be based in Madrid, Spain, but flexibility is appreciated.
Contact Information
For further information on this position, please contact María González De Castro, Quality Assurance Senior Manager, or the People department.
