QA Specialist

EDV Werke is looking for a QA Specialist

Working Model: Remote – European Union

Form of cooperation: B2B Contract

Key Responsibilities:

• Compliance Reporting – Generate and maintain accurate reports of compliance activities, including trending of key quality indicators such as non-conformities, CAPAs, changes, and training metrics.
• Document Implementation – Support the local implementation of global corporate quality documents and ensure alignment with site procedures.
• Cross-Functional Collaboration – Work with multiple departments to promote QMS harmonization across the entire site.
• QMS Projects – Lead and manage projects focused on Quality Management System improvements tailored to site-specific needs.
• Audit & Inspection Support – Actively participate in audits and inspections, including preparation, execution, and follow-up activities.
• Deviation and Change Control – Support deviation assessments, including evaluating criticality and facilitating appropriate resolution processes.
• General QA Support – Perform other duties as assigned to ensure continuous improvement and compliance of the site’s QMS.

Must-Have Skills:

• Educational Background – Bachelor’s or Master’s degree in natural sciences or a related field.
• Relevant Experience – At least 3 years of experience in a GMP-regulated environment, ideally within a Quality unit, to reduce onboarding time.
• Communication Skills – Fluent in English (written and spoken); German is an advantage but not mandatory.
• Multitasking & Stakeholder Management – Proven ability to manage multiple tasks and effectively interact with various internal stakeholders.
• Quality Systems Knowledge – Familiarity with QMS tools such as TrackWise and DMS is strongly preferred for rapid onboarding.
• Deviation Management Expertise – Solid understanding of deviation handling, including assessing deviation criticality and CAPA planning.
• IT Proficiency – Strong skills in Microsoft Excel and PowerPoint to manage data and present quality metrics.

Benefits:

• Competitive salary with performance-based bonuses.
• Opportunities for professional development and advancement.
• Dynamic and collaborative work environment.