Covance are currently looking for a Spanish speaker GCP Senior Auditor to conduct audits across our EMEA region. The individual can be home based or office based.
The Senior Auditor is responsible for leading internal and external QA audits per SOPs and Master Audit Plan, assuring that audited systems, processes and their outcome comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
The main responsabilities are:
Leads audit teams in the conduct, reporting an follow up of regional and local QA audits, ensuring compliance to applicable SOP, Master Audit Plan, and within specified timeframe and quality standards
Conducts complex, directed and /or time sensitive audits
Participates in global QA audits
Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
Leads process improvement activities/ SOP creation and revision
Able to support client audits and regulatory inspections
Leads and/or participates in special projects
Represents Audit QA on project teams and other internal forums
Trains and mentors junior staff
Minimum: university/college degree BA/BS (life sciences preferred) or equivalent expertise
Fluent in both English and Spanish. Portuguese would be a plus.
At least 2 years of experience in GCP audits
Experience in site audits and internal TMF audits