This is a process audit job. (not financial) High potential candidates include from the Food and Beverage, Accreditation for Medical Devices, Pharmaceutical or clinical industries.

Candidates must have job stability.

Essential Job Duties:

¨Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representativesample)

¨Contributes to global QA policies on interpretation/ application ofregulations.

¨Provide subject matter expertise to projects Support team in CAPA plancreation.

¨Hosts external audits/inspections e.g., regulatory inspections, strategic clients. Assists with the facilitation of auditresponses.

¨Supports the QA–to-QA relationship with keyclient(s)

¨Delivery of training in performance of audits (basic, intermediate,complex)

¨Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QAorganization.

¨Supports the reporting of quality metrics and implementation of necessary correctiveactions and/or process improvements via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaisonmeetings)

¨Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, asindicated in applicable controlled documents, arefollowed.

¨Other duties as assigned bymanagement.

Minimum Required:

¨5 years in regulatory environment (experience in GXProles)

¨Experience of industry qualitysystems/standards

¨Excellent interpersonal/organizational skills, e.g., communication, decisionmaking, negotiating, problemsolving

¨Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiplescenarios.

Recommended:

¨A minimum of a bachelor’s degree in a Pharmacy, Chemistry or Biology relateddiscipline

¨Postgraduate degree (MSC or equivalent) in science or management relateddiscipline, preferable

¨Experience may be substituted foreducation.