Senior Quality Assurance Specialist
hace 1 mes
Job Summary:
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Alk-Abelló A/S. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and processes.
Key Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems, including Change control, Deviations, CAPA, etc.
- 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 with product contact, and analytical methods validation.
- Provide quality support to technology transfer projects and 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.
- Support a permanent inspection readiness status, provide QA support for regulatory filings, prepare documentation for Material Review Board presentation and meetings, and support QA Management as required.
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.
- Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
- Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations.
About Us:
Alk-Abelló A/S is a global pharmaceutical company that helps people living with allergy. We are driven by a high level of professionalism, integrity, an open-minded approach, and contributing to an inspiring and fun working environment together with colleagues.
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