Senior Quality Assurance Specialist
hace 4 semanas
About the Role:
We are seeking a highly skilled Senior QA Specialist to join our team at Alk-Abelló. As a Senior QA Specialist, you will be responsible for providing support for and being directly responsible for a range of Quality Assurance functions.
Key Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems, including 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.
- Provides on-site guidance in the preparation of procedures and working instructions.
Requirements:
- Minimum of 5 years' experience in the pharmaceutical/biotech industry and 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 knowledge is valuable.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation.
What We Offer:
At Alk-Abelló, we offer a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to making allergy surprisingly simple to manage, and we believe that our employees are key to achieving this goal.
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