Quality Assurance Expert with Pharmaceutical Industry Knowledge
hace 3 semanas
We are seeking a highly skilled Senior QA Specialist to join our team at Alk Nordic A/S. As a Senior QA Specialist, you will be responsible for providing support and guidance on Quality Assurance functions across various departments.
Key Responsibilities:- Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports: Manufacturing and packaging processes, Computer/Automated systems involved in testing, manufacturing or materials control, Cleaning Validation/Equipment cleaning procedures, Laboratory and manufacturing equipment qualification, Facilities and Utilities with product contact, Analytical methods validation.
- Provide quality support to technology transfer projects.
- 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 support a permanent inspection readiness status.
- Provide QA support for regulatory filings.
- Prepare documentation for Material Review Board presentation and meetings.
- Minimum of 5 years' experience in the pharmaceutical/biotech industry.
- 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 knowledge is valuable.
Alk Nordic A/S is a global pharmaceutical company dedicated to helping people living with allergies. We strive to make improvements that lead to better economy, quality, and social responsibility.
SalaryThe estimated salary for this position is approximately €80,000 - €110,000 per year, depending on experience.
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