Gcp/gvp Auditor

vor 4 Wochen

Basel, Schweiz Coopers Group AG Vollzeit

**GCP/GVP Auditor**

The purpose of the position is to perform internal and external GCP & GVP Audits and contribute to develop and maintain the global audit strategy and audit programs.

She/she will be responsible for audits/self-inspections within QMS as well as external audits of CMOs, suppliers and service providers.

**Responsibilities**:

- Support the strategic development of an effective global risk-based audit strategy (internal & external) and program. Collect and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, and follow-up of GCP/GVP audit as Lead Auditor or Co Auditor ( internal audits/self-inspections within QMS as well as external audits of CMOs, suppliers and service providers) according to the requirements specified in the respective procedures (as well as applicable regulations, standards, quality agreements, and guidance documents) working in strong collaboration with the Audit coordinator and relevant stakeholders.
- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up. Ensure adequate definition and recording of mitigation plans when applicable.
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Audit coordinator and other stakeholder QA representative and Auditee.
- Support Authority inspections and partner audits.
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug.
- Development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations.
- SOP Author for SOPs related to audits including supporting documents.

**Requirements**:

- University degree in Life Sciences or related discipline
- At least 5 years of relevant experience in GCP and GVP audits

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