• Contract
  • Valais
  • Recruiter: Anil Dahiya

 

QA Auditor (CAPEX Projects) – 5903 ADA

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Auditor (CAPEX Projects) based in VispSwitzerland for a contract position.

 

Main 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 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.

 

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.

 

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • BSc/MSc in Engineering, Biotechnology, or Science
  • Experience in Auditing: 5 years plus.
  • Experience of working on CAPEX projects in GMP environments
  • Knowledge of GMP and GXP guidelines