Company Description Job Description Responsibilities Perform GCP quality assurance projects which fall within the job holder's areas of expertise on behalf of client companies within the pharmaceutical industry. Contribute to upskilling of consultants in the conduct of vendor and systems audits. Actively participate in the ADAMAS Learning Management System. Assist with business development activities. Perform other reasonable duties as requested by the job holder's Line Manager. Leading, planning, conducting, documenting and following-up of global GCP audits according to applicable regulations, standards, quality agreements, and guidance documents. Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trends that impact GCP. Qualifications Requirements BSc in Life Science Preferred. Experience in conducting and leading internal and external GCP audits for a variety of stakeholders. Experience in conducting a range of service provider audits (e.g., full service CRO, biostatistics, data management, phase I). Experience in conducting GCP systems audits. Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site. Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage. Expert knowledge of national and international GCP legislation and guidelines. Proficient in managing projects and ensuring deliverables are provided on time. Ability to identify issues and offer solutions in a pragmatic way. Ability to travel up to 40% and the ability to conduct remote audits. Data management experience a plus. Additional Information Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business. We place great worth on development and collaboration so we can best succeed together. When needed, we also place great importance on intellectual curiosity and the ability to work autonomously.
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