Auditor II, QA, GCP Exp Required

Syneos Health

. Conduct audits to assess compliance with applicable regulations, company policies, SOPs, work instructions, contracts, and project-specific requirements .

Posted 9/21/2026full-timeHyderabad • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP quality assurance auditing, including conducting audits, writing reports, and ensuring compliance with regulatory requirements. Strong communication and organizational skills are essential for effectively managing audits and interacting with diverse stakeholders.

Highest-signal resume keywords

GxP Quality Assurance AuditingAudit Report WritingRegulatory ComplianceMicrosoft Office SuiteInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP Regulatory RequirementsAudit ConductingMedical TerminologyTechnical TerminologyReport Writing

Soft Skills

Organizational SkillsPresentation SkillsCultural SensitivityNegotiation SkillsConstructive Feedback

Tools & Technologies

Microsoft Office SuiteSharePoint

Industry Keywords

Compliance AuditsQuality AssuranceRegulatory Authority InspectionsSOPsWork Instructions

About the role

Key responsibilities & impact

Conduct audits to assess compliance with applicable regulations, company policies, SOPs, work instructions, contracts, and project-specific requirements
Host and support customer audits and regulatory inspections in accordance with QA SOPs and work instructions
Plan and conduct assigned Syneos Health audits
Write and issue audit reports, clearly communicating findings to auditees and relevant management
Review responses to audit findings for appropriateness and completeness
Close assigned audits
Prepare for and host or support customer audits
Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections
Perform other work-related duties as assigned

Requirements

What you’ll need

Bachelor’s degree in the science/health care field or equivalent with moderate experience in GxP quality assurance auditing
Good knowledge of GxP regulatory requirements
Knowledge of medical and technical terminology related to the audit types conducted
Computer literacy, including Microsoft Office suite and basic SharePoint proficiency
Ability to handle multiple tasks and meet timelines in a dynamic environment
Strong organizational, presentation, and interpersonal skills
Cultural sensitivity for effective communication with stakeholders from diverse cultural backgrounds
Ability to negotiate and provide constructive feedback
Well-developed communication skills
Ability to write concise, accurate reports and other necessary documentation
Moderate travel may be required, up to 50%

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, for employees or applicants with disabilities