Are you a Senior QA Specialist with a solid understanding of GCP along with proven experience with DCT (De-Centralized Trials)?
Do you have a working knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs, within a global organization?
If this sounds like you, then come and join our growing QA Division at Covance by Labcorp!
As the Senior Auditor - QA Compliance at Covance, you will be fully responsible for leading internal and external QA audits per SOPs and Master Audit Plan, assuring that audited systems, processes and their outcomes comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.
- Leads audit teams in the conduct, reproting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and qualoty standards
- Conducts complex, directed, and/or time sensitive QA audits
- Participate in global QA audits
- Provides suitable recommendations for audit obersvations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriare, 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 poject teams and other internal forums
- Trains and mentors junior staff
- University/college degree BA/BS (life science preferred) or equivalent experience
- Experience with DCT (De-centralised trials)
- Knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
- Knowledge of the drug development process from the perspective of a contract research organisation
- Excellent organization and planning skills and attention to details
- Proven interpersonal skills
- Demonstrated ability to handle competing priorities across clinical operating unit
- Ability to function as a member of a global clinical team
If this sounds like you, then please apply with your CV in English.
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