Our client, an international pharmaceutical company operating in a highly regulated environment, is seeking an experienced Principal and Corporate Lead Auditor to lead audits and ensure compliance and inspection readiness.
KEY RESPONSIBILITIES:
- Plan, conduct, report and follow up on internal and external audits.
- Contribute to annual internal and external audit planning.
- Support sites in defining and implementing audit CAPAs.
- Conduct audits of CMOs, manufacturers, suppliers and relevant GxP service providers according to qualification.
- Escalate significant compliance issues and provide guidance on appropriate actions.
- Support customer audits and regulatory inspections and act as Subject Matter Expert when required.
- Support and mentor Part-Time Lead Auditors (PTLAs).
- Provide audit and compliance guidance and training to internal stakeholders and external partners.
- Contribute to audit trend analysis and identification of systemic or global compliance gaps.
- Support relevant global Quality initiatives and projects.
REQUIRED QUALITIES AND SKILLS:
Lead Auditor
- Relevant scientific university degree.
- Relevant experience in GMP/GxP Quality and auditing.
- Typically 5-7 years of relevant audit/GMP experience.
- Lead Auditor qualification according to applicable procedures.
- Good communication skills and fluent English.
- Ability and willingness to travel.
Principal Lead Auditor
- Meets the Lead Auditor requirements.
- Typically 7–10 years of relevant audit/GMP experience.
- Broad experience across different GxP areas, suppliers and service providers.
- Able to independently handle complex audits and compliance matters and provide expert guidance to other auditors and stakeholders.
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