Auditor- GLP

Main Responsibilities

• Coverage of assigned external audits of non-clinical facilities and safety laboratories.
• Development and issuance of comprehensive Audit Reports, categorizing findings by risk level and recommending corrective and preventive actions (CAPA).
• Identification and communication of non-compliance trends and systematic risks within the Non-clinical (GRLP/GLP/GCLP) discipline to line management and clinical functional leads.
• Supporting initiatives to improve standard operating procedures (SOPs) for audit conduct and collaborating with stakeholders on risk-based, compliant solutions for non-clinical trial management.
• Maintaining up-to-date knowledge of global GLP regulations (ICH Safety Guidelines) and industry trends, identifying new requirements to ensure high-quality non-clinical development programs.

Position Qualifications & Experience

• Academic Background: BS degree in relevant biological science, science, or related discipline.
• Professional Experience: 3+ years of Quality Assurance experience within a pre-clinical and safety laboratory environment, demonstrating a strong understanding of preclinical trials, monitoring, and regulatory frameworks.
• Audit Expertise: Experience in preclinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the preclinical research discipline.
• Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with external vendors providing relevant services.
• Working Knowledge: OECD principles of GLP, ICH Safety Guidelines, ICH M3(R2) Guideline, ICH M10 Guideline, 21 CFR Part 58 – Good Laboratory Practice (GLP), Directives 2004/9/EC and 2004/10/EC (GLP Directives).
• Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.