GCP Auditor – Porto Alegre, Brazil (Ad hoc)

Planet Pharma; Porto Alegre; On-site; BRL 221,000 - 332,000; Part time

Job summary

Planet Pharma seeks a skilled GCP Auditor to conduct Investigator Site Audits in Porto Alegre, Brazil on an ad hoc, 2-day on-site basis. The role ensures compliance with GCP, CFR and ICH E6 across sites, with meticulous documentation and timely reporting.

You'll collaborate with international teams, communicate in Portuguese and English, and travel as needed within a short-term engagement designed to uphold patient safety and trial integrity.

Qualifications

• Minimum of 5 years' experience in GCP audits, particularly Investigator Site Audits.
• Fluency in Portuguese and English, with excellent communication skills.
• Strong understanding of GCP guidelines, CFR, ICH E6, and related regulations.
• Proven ability to conduct rigorous audits and manage documentation meticulously.
• Self-motivated with the capacity to work independently on-site for 2 days.
• Nice to have: experience in Brazil's regulatory environment and GCP certification.
• Preferred education: Life Sciences/Pharmacy/Medicine degree with hands-on oversight.

Responsibilities

• Perform comprehensive GCP-ISA audits at investigator sites in Porto Alegre.
• Apply your expertise to assess compliance with regulatory standards and sponsor requirements.
• Collaborate with international teams, ensuring clear communication in Portuguese and English.
• Deliver detailed audit reports within tight deadlines, contributing to trial integrity.

Skills

GCP audits

Portuguese & English

GCP CFR ICH E6 knowledge

Audit documentation

Independent on-site work

Education

Bachelor's degree or higher in Life Sciences, Pharmacy, Medicine

Job description

GCP Auditor - Porto Alegre, Brazil (Ad hoc)

Join a dynamic team committed to advancing healthcare innovation by ensuring the highest standards of Good Clinical Practice (GCP) compliance. We are seeking a highly experienced GCP Auditor to conduct critical Investigator Site Audits (ISA) in Porto Alegre, Brazil. This short-term, impactful opportunity is perfect for professionals who thrive in a fast-paced environment and are passionate about improving patient safety and clinical quality.

What You'll Do:

• Perform comprehensive GCP-ISA audits at investigator sites in Porto Alegre.
• Apply your expertise to assess compliance with regulatory standards and sponsor requirements.
• Collaborate seamlessly with international teams, ensuring clear communication in both Portuguese and English.
• Deliver detailed audit reports within tight deadlines, contributing to the integrity of clinical trials.

Required Skills:

• Minimum of 5 years' experience in GCP audits, particularly Investigator Site Audits.
• Fluency in Portuguese and English, with excellent communication skills.
• Strong understanding of GCP guidelines, CFR, ICH E6, and related regulations.
• Proven ability to conduct rigorous audits and manage documentation meticulously.
• Self-motivated with the capacity to work independently on-site for 2 days.

Nice to Have Skills:

• Prior experience working within Brazil's regulatory environment.
• Knowledge of local clinical research practices and cultural nuances.
• Certification in GCP or related compliance areas.

Preferred Education and Experience:

• Bachelor's degree or higher in Life Sciences, Pharmacy, Medicine, or related fields.
• Extensive hands-on experience in clinical trial oversight and compliance.
• Experience working with multinational pharmaceutical or biotech companies.

Other Requirements:

• Availability to conduct audits on one of the following date blocks: 8-9 September, 22-23 September, or 29-30 September 2026.
• Ability to travel to Porto Alegre; candidates outside the region will be considered if reasonably accessible.
• Must be prepared for an ad hoc, 2-day onsite engagement in September 2026.

Take this chance to make a tangible impact on the future of healthcare.