QA Auditor, CAPEX

Start date: Immediately

End date: 31.12.2024

Location: Valais, onsite

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.
  Goals
• Guarantee Compliance: Ensure all elements of CAPEX projects comply with GMP standards, focusing on design integrity and operational effectiveness.
• Maintain Regulatory Standards: Lead efforts to keep projects aligned with industry regulations and internal quality benchmarks.

Requirements:

• 5 years of experience in a similar position
• Knowledge of GMP
• Experience in CAPEX projects