Pharmaceutical Quality GMP Auditor – Consulting

Advarra

. Conduct Good Manufacturing Practice (GMP) audits, including planning, agenda development, physical or remote audits, and report writing .

Posted 11/6/2026part-timeSão Paulo • BrazilSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance and Good Manufacturing Practice (GMP) auditing, including the ability to conduct audits, prepare detailed reports, and implement corrective actions. Proficient in regulatory compliance with FDA and EMA standards, with strong communication skills in English and Portuguese.

Highest-signal resume keywords

10+ Years Of Quality Assurance Experience5+ Years Of GMP Auditing ExperienceRegulatory Compliance With FDA And EMAB2 Level English CommunicationB2 Level Portuguese Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Good Manufacturing Practice (GMP) AuditsAudit Report WritingQuality Assurance Plans DevelopmentAudit Programs ImplementationCorrective Action PlansAudit Readiness ActivitiesRoot Cause Analysis

Soft Skills

Interpersonal SkillsClient Interaction SkillsAnalytical SkillsProblem-Solving SkillsCommunication Skills

Certifications & Qualifications

Bachelor's DegreeRegistration In Advarra’s Expert Network

About the role

Key responsibilities & impact

Conduct Good Manufacturing Practice (GMP) audits, including planning, agenda development, physical or remote audits, and report writing
Evaluate CROs and vendor compliance or qualification
Prepare comprehensive audit reports detailing findings and root causes
Provide written audit reports in English
Support corrective actions when required
Present findings to QA leadership and stakeholders when required
Work collaboratively with clients to ensure quality standards
Join Advarra’s consultant network for South American-based projects

Requirements

What you’ll need

Minimum 10+ years of Quality Assurance and/or Good Manufacturing Practice (GMP) experience
Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience
Demonstrated experience with regulatory agency expectations, including FDA and EMA
Demonstrated experience in audit readiness activities
Demonstrated experience developing and implementing quality assurance plans, audit programs, and corrective action plans
B2 level English communication, verbal and written
B2 level Portuguese communication, verbal and written
Bachelor's degree
Strong interpersonal and client interaction skills
Excellent analytical, problem-solving, communication, and report-writing skills
Ability to work collaboratively across departments and interact with internal and external stakeholders
Registration in Advarra’s expert network is required to be considered

Benefits

Comp & perks

Inclusive and collaborative work environment
Consultants are part of Advarra’s consultant network
Opportunity to support clinical research advancing patient health
Reasonable accommodation available for applicants with disabilities