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GCP Auditor

Barrington James

São Paulo, SP - há 1 hora

Descrição do trabalho

We are seeking a detail-oriented and knowledgeable GCP/GLP Auditor with specialized experience in veterinary medicine to join our Quality Assurance team. The successful candidate will play a critical role in ensuring that our preclinical and clinical studies are conducted in accordance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards, as well as applicable regulatory and ethical guidelines specific to veterinary pharmaceuticals and animal health products.

Key Responsibilities:

Plan, conduct, and report GCP and GLP audits for veterinary clinical and non-clinical studies, including protocol, data, and site audits.
Ensure compliance with relevant international regulations (e.g., VICH, EMA, FDA, OECD) and internal SOPs.
Evaluate study documentation and processes to ensure integrity, traceability, and reliability of data.
Audit CROs, laboratories, and investigator sites involved in veterinary trials to assess GCP/GLP adherence.
Collaborate with study teams, regulatory affairs, and third-party vendors to identify and address quality issues.
Provide training and guidance on GCP/GLP requirements and best practices specific to veterinary medicine.
Participate in regulatory inspections and support the preparation of audit response plans.
Track and follow up on audit findings and corrective/preventive actions (CAPAs) to ensure timely closure.
Maintain detailed and accurate audit records and reports in line with company and regulatory expectations.

Qualifications:

Bachelor’s or advanced degree in Veterinary Science, Life Sciences, Animal Health, or related field.
Minimum of 3–5 years of auditing experience in a GCP and/or GLP environment, ideally within the veterinary or animal health industry.
In-depth understanding of veterinary clinical and preclinical trial processes and applicable regulations.
Certification in auditing (e.g., RQA, ASQ) preferred.
Strong knowledge of international regulatory guidelines (VICH, EMA, FDA, OECD).
Excellent written and verbal communication skills.
Ability to travel as needed (domestic and/or international).

Preferred Skills:

Experience working with regulatory submissions for veterinary medicines.
Familiarity with electronic systems (e.g., eTMF, QMS, LIMS).
Ability to work independently and collaboratively in a cross-functional environment.
Strong analytical, organizational, and problem-solving skills.

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