QA Specialist (5016)

Gi Group Switzerland; Lugano; Vor Ort; CHF 30’000 - 80’000; Vollzeit

Zusammenfassung

A leading international Life Sciences company in Lugano, Switzerland, is seeking a Quality Assurance Specialist to ensure quality and compliance across manufacturing processes. This role demands strong regulatory expertise and confidence in managing validation projects. Responsibilities include ownership of qualification activities, addressing quality issues, and providing guidance to QA teams. Candidates should have a technical degree and proven QA experience. This permanent position offers visibility within a structured organization and exposure to high-impact projects.

Leistungen

Permanent position

High visibility within the organization

Exposure to high-impact projects

Qualifikationen

• Proven experience in Quality Assurance within pharmaceutical or medical device environments.
• In-depth knowledge of international regulatory frameworks (GMP, FDA, ISO 13485, ISO 15378, ICH).
• Strong understanding of industrial manufacturing processes.

Aufgaben

• Take ownership of qualification and validation activities.
• Ensure consistency and soundness of validation documentation.
• Lead resolution of complex quality issues.

Kenntnisse

Quality Assurance

Regulatory compliance

Analytical mindset

Communication skills

Ausbildung

Technical degree in Engineering or related scientific discipline

Tools

Statistical tools

Jobbeschreibung

Role Summary

Gi Group, Life Sciences division, on behalf of a leading international Life Sciences manufacturing company, we are looking for a Quality Assurance Specialist.

The QA Specialist will play a central role in ensuring that quality, compliance and risk-based principles are embedded across manufacturing processes, systems and projects.

The position requires a high degree of autonomy, strong regulatory expertise and the ability to interact confidently with internal and external stakeholders in an international context.

Key Responsibilities

• Take end-to-end ownership of qualification and validation activities for processes, equipment, environments and computerized systems in regulated manufacturing settings.
• Define, implement and maintain qualification and validation strategies aligned with international regulations and internal quality standards.
• Actively contribute to project governance by integrating quality and risk-based thinking into technical and operational decisions.
• Ensure the robustness, consistency and regulatory soundness of validation documentation and technical justifications.
• Lead the assessment, investigation and resolution of complex quality issues, deviations and non-conformities, proposing sustainable and compliant solutions.
• Critically evaluate process performance and validation data using statistical and analytical tools to support compliance-driven decisions.
• Represent Quality in interactions with customers, regulatory authorities, notified bodies and internal stakeholders, particularly on qualification and validation topics.
• Provide guidance and technical support to QA colleagues and contribute to continuous improvement and quality system enhancement initiatives.

Experience & Skills

• Technical degree, preferably in Engineering or a related scientific discipline.
• Proven experience in Quality Assurance within pharmaceutical and / or medical device environments, with solid exposure to qualification and validation activities.
• In-depth knowledge of international regulatory frameworks (GMP, FDA, ISO 13485, ISO 15378, ICH).
• Strong understanding of industrial manufacturing processes, ideally including plastic moulding and components assembly.
• Demonstrated ability to manage complex validation projects with limited supervision.
• Strong analytical mindset, with confidence in applying statistical tools and data-driven approaches.
• High level of autonomy, accountability and risk-based quality thinking.
• Excellent communication skills and ability to operate effectively in cross-functional and multicultural environments.
• Fluent English, both written and spoken.

What's in It for You

• Permanent position with high visibility within a structured international Life Sciences organization.
• Exposure to technically complex and high-impact projects in a regulated environment.
• Opportunity to operate as a trusted quality reference within the organization.