Parexel

Audit Specialist – Sponsor Audits and Inspections

Parexel

full-time

Posted on:

Location Type: Remote

Location: Serbia

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Job Level

Junior

Tech Stack

Google Cloud Platform

About the role

  • Independently plan, conduct, and report on audits across all clinical research phases, including project audits, system audits, supplier qualifications, TMF audits, and pharmacovigilance audits
  • Complete high-quality audit reports within timelines and budgets, including complex for-cause and co-audits with clients
  • Support Serious Breach investigations, provide regulatory guidance on GxP requirements, and facilitate client audits and regulatory inspections
  • Review CAPA responses, escalate delays, and consult with Operations and Quality teams on implementation
  • Help develop and improve Parexel procedures, systems, and audit strategies

Requirements

  • Practical experience in GxP environments (GCP and GVP standards preferred)
  • Background in Quality Management/Quality Assurance with hands-on involvement in external audits and regulatory inspections
  • Fluent English (spoken and written) and good level of the local language of the country you are applying from
  • Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams/SharePoint)
  • Strong decision-making ability with quick analytical thinking
  • Excellent communication skills at all organizational levels
  • High adaptability to respond to fast-moving, externally driven changes
  • Demonstrated leadership and ability to influence cross-functional teams
  • Willingness to travel occasionally
  • Bachelor's Degree (Life Science, Health, or industry-related discipline preferred)
Benefits
  • Health insurance
  • Flexible working arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
audit planningaudit reportingGxP complianceCAPA reviewregulatory guidancepharmacovigilancequality managementquality assuranceexternal auditsregulatory inspections
Soft Skills
decision-makinganalytical thinkingcommunicationadaptabilityleadershipinfluencingcollaborationproblem-solvingtime managementclient relations