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Alk-Abelló, A/S is seeking a highly skilled Senior QA Specialist to join our team. As a Senior QA Specialist, you will be responsible for providing support for and being directly responsible for a range of Quality Assurance functions.
This position will contribute to ensuring that performance of manufacturing, packaging operations, and product quality conforms to established cGMPs to ensure lasting customer satisfaction.
This individual 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.
- 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.
- 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.
- Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal with organisational complexity and ambiguity.
- Ideally experience in Medical Devices.
