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Senior QA Specialist
hace 2 meses
**Job Overview**
We are seeking an experienced Senior QA Specialist to join our team at Alk-Abelló, A/S. As a key member of our quality assurance department, you will play a crucial role in ensuring the highest standards of quality and compliance.
**Salary:** DKK 95,000 - 125,000 per annum (depending on experience)
**About the Role**
The successful candidate will be responsible for providing support and guidance on a range of Quality Assurance functions, including change control, deviations, CAPA, and regulatory filings. You will work closely with cross-functional teams to ensure that all processes and procedures meet the required standards of quality and compliance.
**Key Responsibilities**
- Perform Quality Assurance activities associated with maintaining internal Quality Systems, including change control, deviations, and CAPA
- Review GMP technical and validation reports, including manufacturing and packaging processes, computer/automated systems, cleaning validation/equipment cleaning procedures, laboratory and manufacturing equipment qualification, facilities and utilities, analytical methods validation, and technology transfer projects.
- Provide quality support to technology transfer projects, prepare documentation for Material Review Board presentation and meetings, and assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training, and coaching of relevant personnel.
- Help support a permanent inspection readiness status and provide QA support for regulatory filings.
- Collaborate with cross-functional teams to ensure that all processes and procedures meet the required standards of quality and compliance.
**Requirements**
- Minimum of 5 years' experience in the pharmaceutical/biotech industry, with a thorough knowledge of quality systems, GMP, and regulatory requirements.
- University degree in Chemistry, Pharmacy, Biology, or equivalent.
- Fluent in communications (both written and spoken) in English.
- Thorough knowledge in sterile products regulation, oral solids forms, and technology transfer projects.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation, and strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations.
**Benefits**
- Competitive salary and benefits package.
- Opportunity to work with a global pharmaceutical company that helps people living with allergy.
- Collaborative and dynamic work environment.
**About Us**
Alk-Abelló, A/S is a leading manufacturer of pharmaceuticals and biotechnology products. We are committed to delivering high-quality products and services that meet the needs of our customers and patients.
