Ready to explore a new career development opportunity?
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world.
Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities. There's no better time to join us!
As a Good Clinical Practice (GCP) Auditor you will:
- Assure all systems, processes and their outcomes comply with standards that meet applicable ICH-GCP and national regulations and guidelines, as well as fulfil client and Covance requirements.
- Assure that all projects have an Audit Plan written and are completed on time and within budget
Job Duties and Responsibilities:
- Lead audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
- Leads complex audits (e.g., directed, process, systems, office)
- Provide 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
- Proactively identifies and leads process improvement activities / SOP creation and revisions
- Able to host client audits and able to support regulatory inspections
- Leads and/or participates in special projects
- Represents Audit QA on project teams and other internal forums
- Trains and mentors junior QA Audit staff/ support on-boarding of new personnel
- University/college degree BA/BS (life science preferred),or equivalent
- Thorough 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 organization
- Typically 5 years CRO/Pharmaceutical experience of which 4 years in a GXP quality role, including at least 2 years in a GCP quality role required
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