GCP QA Auditor - Lead Audits, CAPA & Compliance

Novotech; Sydney; Presencial; AUD 80.000 - 120.000; Tempo integral

Resumo da vaga

Novotech is seeking qualified QA Auditors to lead and perform audits across investigator sites, vendors, and internal processes. The role emphasizes strong customer focus, top‑level communication, and timely CAPA implementation within a GCP QA framework.

Candidates should have tertiary life sciences qualifications and several years of QA/GCP experience, with the ability to work independently and maintain up‑to‑date knowledge of national and international guidelines.

Qualificações

• Strong customer focus and attention to detail are essential.
• Excellent communication and interpersonal skills are required.
• Ability to multi-task and work independently in a QA/GCP environment.

Responsabilidades

• Plan and host client audits and regulatory inspections of Novotech.
• Perform audits of investigator sites, vendors, TMF, and internal processes.
• Ensure audit results are recorded and reported promptly and CAPA actions are implemented.
• Participate in investigation and evaluation of quality events and root cause analysis.
• Evaluate third‑party vendors for clinical trial services.

Conhecimentos

Strong customer focus

Excellent communication

Interpersonal skills

Attention to detail

English proficiency

Formação

Tertiary qualifications in life sciences or related field

Descrição da vaga

Novotech is seeking qualified QA Auditors to lead and perform audits across investigator sites, vendors, and internal processes. The role emphasizes strong customer focus, top‑level communication, and timely CAPA implementation within a GCP QA framework.

Candidates should have tertiary life sciences qualifications and several years of QA/GCP experience, with the ability to work independently and maintain up‑to‑date knowledge of national and international guidelines.