Quality Assurance Specialist
hace 4 días
About the Role:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Alk-Abelló Nordic. As a Senior QA Specialist, you will be responsible for ensuring the performance of manufacturing, packaging operations, and product quality conforms to established cGMPs.
This is a unique opportunity to work in a global pharmaceutical company that helps people living with allergy. You will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.
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.
- Support QA Management as required, Provide GMP quality expertise, advice, and/or assistance across the organization as required.
Requirements:
We are looking for a candidate with 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 is also required.
The ideal candidate will have fluency in written and spoken English, thorough knowledge of sterile products regulation, and 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, capable of handling organizational complexity and ambiguity are also essential.
What We Offer:
We offer a competitive salary of approximately $85,000 per annum, depending on experience. Our company culture values innovation, teamwork, and continuous learning, making it an exciting place to work. If you are passionate about quality and committed to excellence, we encourage you to apply for this challenging and rewarding role.
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