Pharmaceutical Quality GMP Auditor (Consulting)

Advarra; Brasil; Hybrid; BRL 455,000 - 834,000; Part time

Job summary

Advarra is seeking a Pharmaceutical Quality GMP Auditor to join our consultant network for South American projects. This hybrid, part-time consulting role conducts GMP audits across sites and vendors to support compliance and continuous improvement.

You will lead audit planning, assessments, and report writing, evaluate CROs, develop corrective actions, and present findings to QA leadership. Strong English and Portuguese communication skills are required, with experience in regulatory

Qualifications

• Minimum 10+ years of Quality Assurance and/or GMP experience.
• Minimum 5+ years of GMP auditing experience.
• Regulatory agency expectations (FDA, EMA) and audit readiness.
• Experience developing QA plans, audit programs, and corrective action plans.
• B2 level in English communication, verbal and written.
• B2 level in Portuguese communication, verbal and written.

Responsibilities

• Conduct GMP audits (planning, agenda, remote/onsite audit, report writing).
• Evaluate CROs and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root causes.
• Provide corrective actions support and present findings to QA leadership and stakeholders.
• Work collaboratively with clients to ensure quality standards.

Skills

GMP auditing

Quality Assurance

Regulatory knowledge FDA/EMA

Audit report writing

English (B2)

Portuguese (B2)

Job description

Pharmaceutical Quality GMP Auditor (Consulting)

Locations

Showing 1 location

• Hybrid
• Consultant
• Part-Time
• Requisition #: PHARM004867

Description

Location

This role is open to candidates based in South America.

Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

Advarra is seeking Good Manufacturing Practice (GMP) Auditors to join our consultant network for South American-based projects. Auditors support compliance reviews across GMP sites and vendors.

Job Duties & Responsibilities

• Conduct Good Manufacturing Practice (GMP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Basic Qualifications

• 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 (e.g., FDA, EMA) and audit readiness activities.
• Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
• B2 level in English communication, verbal and written
• B2 level in Portuguese communication, verbal and written

Preferred Qualifications

• 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.