EPM Scientific
We are working with a mid-sized biotech company that works with cell and immunotherapy products designed to help strengthen the immune system of patients in need.
Their specialty areas include Immunotherapy, Oncology, Cell Therapy, and more as they expand their sciences.
Job Overview
The client is looking for a Sr GCP Auditor who is well seasoned with auditing in the clinical space (more specifically in CROs and investigator sites). Responsibilities
Essential Functions: Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices. Contribute to the development and review of SOPs and other controlled documents (forms, templates, work instructions). Ensure compliance with SOPs and ICH GCP E6 (R2) standards. Schedule, plan, coordinate, and conduct vendor/supplier audits, internal audits, compliance visits, for cause audits, and clinical trial site audits. Prepare required documentation to support audit activities, including audit plans, audit reports, audit certificates, and corrective action plans. Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. Requirements
Skill Requirements: Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines. Strong problem-solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously. Demonstrated understanding and application of ICH GCP E6 (R2). Proficient in communication, both verbal and written, and able to multitask across multiple functional areas. Timeline-focused and flexible in work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company. Details
Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Quality Assurance. Industry: Pharmaceutical Manufacturing. : We are an equal opportunities employer and welcome applications from all qualified candidates.
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The client is looking for a Sr GCP Auditor who is well seasoned with auditing in the clinical space (more specifically in CROs and investigator sites). Responsibilities
Essential Functions: Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices. Contribute to the development and review of SOPs and other controlled documents (forms, templates, work instructions). Ensure compliance with SOPs and ICH GCP E6 (R2) standards. Schedule, plan, coordinate, and conduct vendor/supplier audits, internal audits, compliance visits, for cause audits, and clinical trial site audits. Prepare required documentation to support audit activities, including audit plans, audit reports, audit certificates, and corrective action plans. Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. Requirements
Skill Requirements: Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines. Strong problem-solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously. Demonstrated understanding and application of ICH GCP E6 (R2). Proficient in communication, both verbal and written, and able to multitask across multiple functional areas. Timeline-focused and flexible in work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company. Details
Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Quality Assurance. Industry: Pharmaceutical Manufacturing. : We are an equal opportunities employer and welcome applications from all qualified candidates.
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