Sr GCP Auditor
We are working with a mid-sized biotech company that works with cell and immunotherapy products which are designed to help strengthen the immune system of patients in need.
Some of their specialty areas include Immunotherapy, Oncology, Cell Therapy, and much more as they are proactively expanding their sciences.
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).
Essential Functions:
- Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
- Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
- Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
- Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits
- Prepares 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.
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
Multitasks across multiple functional areas - Timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.
If you have extensive with GCP auditing in the pharma/biotech industry and feel that you'd be a good fit for this role based on the requirements listed, please apply!
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