Senior Quality Assurance Specialist
hace 11 horas
Alk Nordic A/S is a leading global pharmaceutical company that prioritizes quality and customer satisfaction. As a Senior QA Specialist, you will play a crucial role in ensuring the performance of manufacturing, packaging operations, and product quality meets established cGMPs.
About the RoleThis senior-level position requires a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented. You will be directly responsible for performing Quality Assurance activities associated with maintaining internal Quality Systems, including Change control, Deviations, CAPA, etc.
Key Responsibilities- Review GMP technical and validation reports for 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, and analytical methods validation.
- Provide quality support to technology transfer projects and 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 and provide QA support for regulatory filings.
We are seeking an individual with a minimum of 5 years' experience in the pharmaceutical/biotech industry and a thorough knowledge of quality systems, GMP, and regulatory requirements. The ideal candidate will have a university degree in Chemistry, Pharmacy, Biology, or equivalent and expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation.
What We OfferThe estimated salary for this position is between $90,000 and $110,000 per year, depending on qualifications and location. In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Join Our TeamIf you are passionate about working in a global pharmaceutical company that prioritizes quality and customer satisfaction, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information].
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