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About the role
Key responsibilities & impact- Lead, Perform and Report audits
- Manage GxP audits
- Collect and review responses to audit findings
- Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs
- Lead and coordinate internal audit programs
- Arrange meetings with client and other key stakeholders as required
- Develop and optimize new and existing processes to maintain and improve quality
Requirements
What you’ll need- Minimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing
- At least 7 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science
- Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
- Ability to rapidly learn, understand and apply applicable Parexel and client procedures
- Ability to work flexible and across multicultural environment
- Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Benefits
Comp & perks- Health insurance
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
AuditingQuality ManagementRegulatory ComplianceData ManagementPharmacovigilanceClinical TrialsProcess OptimizationCAPA ImplementationMonitoringLaboratory Practices
Soft Skills
ConsultancyCommunicationFlexibilityCollaborationMulticultural Adaptability