GMP QA Specialist

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An exciting journey for a GMP QA Specialist to join Diamyd Medical's own biologics manufacturing facility in Umeå.

On behalf of the Swedish Biotech company Diamyd Medical we are recruiting an experienced GMP QA Specialist.Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. The lead product, Diamyd, is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The company's confirmatory Phase III trial, DIAGNODE-3, is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the US.

The company has established a new biologics manufacturing site in Umeå for the manufacture of rhGAD65, the active pharmaceutical ingredient in Diamyd, and the development of future assets.Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

The GMP QA Specialist plays a crucial role in ensuring compliance with regulatory requirements and maintaining high-quality standards. As a member of the QA team, you are expected to contribute to and develop parts of the quality system according to EU and FDA GMP guidelines. You are motivated and have several years of experience from pharmaceutical manufacturing and analytical test methods. Experience from working independently and collaboratively in a team-based environment is crucial. You will work in cross functional teams, with colleagues at the manufacturing site but also with colleagues in R&D functions. You will report to the QA manager.

Responsibilities:

• Develop, maintain, monitor, and contribute to continuous improvements of the quality management system to ensure that regulatory requirements are met.
• Handle and/or lead investigations/actions of deviations, changes and CAPAs.
• Be the main QA contact for Quality Control questions and projects.
• Be a QA support in the validation and implementation of analytical methods, many of them bioanalytical.
• Have a QA role in the qualification of equipment, with focus on analytical instruments.
• Review and approve Master batch records, SOPs and other controlling documents, to ensure accuracy, completeness and compliance.
• Review and release ingoing materials based on quality documentation.
• Review Batch manufacturing records and analytical results from batch manufacturing.
• Participate in investigations on quality related deviations and change control errands.
• Participate in regulatory inspections.

Key Requirements:

• M.Sc. or PhD in a relevant scientific discipline (pharmacy, biotechnology, bioengineering, biomedical sciences or similar).
• Several years' experience within QA, working in a GMP environment.
• Proficient in Bioanalytical methods, and analytical method validation.
• Proficient in quality systems.
• Have strong organizational skills.
• Ability to collaborate and work independently.
• Have good communicational skills and appreciate to interact and support colleagues.