Senior Quality Assurance Specialist
hace 1 semana
We are seeking a highly skilled Senior QA Specialist to join our team at Alk-Abelló Nordic. As a key member of our quality assurance department, you will play a critical role in ensuring that our manufacturing, packaging operations, and product quality meet the highest standards of cGMPs.
Responsibilities- Maintain internal Quality Systems: Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports for 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.
- Help maintain a permanent inspection readiness status and provide QA support for regulatory filings.
To be successful in this role, you will need:
- A minimum of 5 years' experience in the pharmaceutical/biotech industry with a thorough knowledge of quality systems, GMP, and regulatory requirements.
- A university degree in Chemistry, Pharmacy, Biology, or equivalent.
- Fluent written and spoken English.
- Thorough knowledge of sterile products regulation and oral solids forms 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 various cultures on non-routine matters in stressful situations.
We offer a competitive salary of €80,000 - €110,000 per year, depending on your level of experience. You will also have access to ongoing training and development opportunities to help you grow your career within our company.
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