Quality Assurance Specialist for Pharmaceutical Operations
hace 1 mes
About the Position
At Alk Abello Spa, we are seeking a highly skilled Quality Assurance Specialist to join our team in Madrid. The ideal candidate will have a strong background in quality systems, GMP, and regulatory requirements.
Job Description
We are looking for a Senior QA Specialist with high proficiency in English to provide support for and be directly responsible for a range of Quality Assurance functions. This position will contribute to ensuring that performance of manufacturing, packaging operations, and product quality conforms to established cGMPs.
The successful candidate will be responsible for performing Quality Assurance activities associated with maintaining internal Quality Systems, reviewing GMP technical and validation reports, and providing quality support to technology transfer projects.
Responsibilities
This role includes:
- Performing Quality Assurance activities associated with maintaining internal Quality Systems
- Reviewing GMP technical and validation reports
- Providing quality support to technology transfer projects
- Providing on-site guidance in the preparation of procedures and working instructions
- Assisting in providing resolution to GMP issues
- Supporting a permanent inspection readiness status
- Preparing documentation for Material Review Board presentation and meetings
- Providing QA support for regulatory filings
- Providing GMP quality expertise, advice, and/or assistance across the organization
Qualifications
To be considered for this role, you should have:
Essential Requirements
- A minimum of 5 years' experience in the pharmaceutical/biotech industry
- A thorough knowledge of quality systems, GMP, and regulatory requirements
- A university degree in Chemistry, Pharmacy, Biology, or equivalent
- Fluent written and spoken English
Prefereable Qualifications
- Experience in Medical Devices
- Knowledge of oral solids forms and technology transfer projects
Location and Benefits
The position is located at Alk's site in Madrid, close to the center of the city. We offer a competitive salary of €65000 - €80000 per year, depending on experience, as well as a remote working policy and access to our canteen for breakfast and lunch every day.
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