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GxPAssure

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2022

💊 Pharmaceuticals

📋 Compliance

💼 Consulting

Pharmaceuticals • Compliance • Consulting

GxPAssure is a London-based pharmaceutical quality and compliance consultancy that provides GxP support to the pharmaceutical and biopharmaceutical industry worldwide. They offer expert consulting, inspection readiness, mock audits, remediation, system reviews, supply chain/CMO audits, regulatory-censure management, training, and contract quality personnel. Their team includes ex-regulators and industry experts with specific experience in sterile manufacturing, biologics, ATMPs (cell & gene therapies), and small-molecule manufacturing, supporting regulatory approvals and remediation for MHRA, FDA, EMA and others.

📋 Description

• Conduct comprehensive assessments of clients' compliance with GxP regulations. • Develop and implement quality management systems tailored to client needs. • Provide training and mentorship to client teams on GxP practices and compliance requirements. • Prepare and review documentation related to regulatory submissions and audits. • Facilitate internal and external audits, providing expert guidance and support. • Analyze client operations and processes to identify areas for improvement and compliance risks. • Collaborate with cross-functional teams to design and execute compliance strategies.

🎯 Requirements

• Bachelor’s degree in a relevant field (e.g., life sciences, engineering, etc.). • Minimum of 5 years of experience in a regulatory compliance or consulting role, preferably within the life sciences industry. • Strong knowledge of GxP guidelines, including GMP, GCP, and GDP regulations. • Excellent communication and interpersonal skills to effectively engage with clients and stakeholders. • Proven ability to analyze complex processes and develop actionable solutions. • Demonstrated project management skills and experience overseeing multiple client engagements. • Willingness to travel as needed for client engagements.

🏖️ Benefits

• Competitive hourly rate • Work From Home