The Sr. Auditor II role is responsible for leading internal and external 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/or Covance requirements. This position is also responsible for hosting and/or supporting client audits and inspections ensuring effective planning for, facilitation of, and follow up to the client audit/inspection outcome.
- Conducts, reports and follows up of QA audits (routine, directed, etc.), ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
- Ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
- Facilitates client audits (preparation, hosting, follow up) and supports regulatory inspections ensuring timely responses and effective management of issues identified to include review and approval of responses/CAPA plans and timely closure of CAPAs
- Proactively identifies and leads/supports process improvement activities / SOP revisions
- 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 country regulatory requirements for the conduct of drug/clinical development programs
- Knowledge of the drug development process from the perspective of a contract research organization
- 4 years CRO/Pharmaceutical experience
- 3 years in a GXP quality role, including at least 1 year in a GCP quality role required
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