We are currently searching for a QA Auditor (Capex projects) for one of our clients, a global bio-pharmaceutical company located in Switzerland,
Responsibilities:
Lead and Co-Auditor:
- Plan and conduct detailed internal audits for ongoing CAPEX projects to ensure compliance with GMP
- Document and report findings, managing follow-up actions to address non-compliance issues
Commissioning & Qualification (C&Q):
- Review and monitor C&Q plans to verify they meet all required GMP standards
- Ensure thorough execution of C&Q activities, confirming alignment with approved protocols
Design and Zone Concept:
- Audit design plans to ensure they adhere to GMP, focusing on layout, material flow, and contamination control
- Evaluate zone concepts for proper segregation and risk management
Compliance with GDOCP and Data Integrity:
- Verify the integrity and completeness of the General Document of Certified Product
- Oversee data management practices to ensure all data complies with GMP and Data Integrity standards
Guarantee Compliance: Ensure all CAPEX projects comply with GMP standards, emphasizing design integrity and operational effectiveness.
Maintain Regulatory Standards: Lead efforts to align projects with industry regulations and internal quality benchmarks.
This role is pivotal in ensuring that new facilities are built and operated in compliance with stringent GMP requirements, safeguarding product quality and regulatory adherence.
For further information about this position, please apply with your CV.
*Please note, only those with the right to work in Switzerland can apply!
