QA Specialist

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

Zusammenfassung

An international Life Sciences manufacturing company located in Switzerland is seeking a Quality Assurance Specialist. This role involves taking ownership of qualification and validation activities, ensuring compliance with international regulations, and leading complex quality issue resolutions. The ideal candidate will hold a technical degree and have significant experience in Quality Assurance within pharmaceutical environments. The position offers a permanent role with exposure to high-impact projects and opportunities for professional growth.

Leistungen

Permanent position with high visibility

Exposure to complex projects

Opportunity to operate as a trusted reference

Qualifikationen

• Proven experience in Quality Assurance within pharmaceutical and/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 end-to-end ownership of qualification and validation activities.
• Lead the assessment and resolution of complex quality issues.
• Critically evaluate process performance using statistical tools.

Kenntnisse

Quality Assurance

Regulatory expertise

Statistical analysis

Communication skills

Risk-based quality thinking

Ausbildung

Technical degree in Engineering or related discipline

Jobbeschreibung

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

Role Summary

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.

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.