Worldwide Companies City

Job Descrption

£65,000 - £70,000

We are seeking a skilled Quality Assurance Professional to join a dynamic team dedicated to developing potentially curative treatments for serious diseases. In this role, you will play a key part in ensuring compliance with regulations and maintaining high standards of quality.

Your responsibilities will include:
• Overseeing compliance with GMP and applicable regulations
• Reviewing batch records and finalizing dispositions
• Providing QA leadership and technical expertise across various operations
• Identifying and addressing quality and compliance risks
• Serving as the Quality liaison for external clients
• Resolving complaints, deviations, and quality incidents promptly
• Staying informed on regulatory changes and facilitating integration into company SOPs
• Assisting with self-inspections and external audits
• Creating and delivering training related to the QMS and other role-specific topics
• Ensuring adherence to GMP, Data Integrity, and Good Documentation... Practices (GDP)
• Closing assigned GMP documentation in a timely manner

Your background:
• Eligibility to act as a Qualified Person as defined in Human Medicines Regulations and Clinical Trial Regulations
• Strong working knowledge of GMP principles and extensive experience in quality assurance within a GxP environment
• Excellent communication skills and the ability to build effective relationships
• Extensive knowledge of pharmaceutical quality assurance and GMP within an operational environment
• Proven track record of improving Quality Management Systems
• Strong understanding of cGMP regulations

Join this groundbreaking organization and play a crucial role in transforming the gene therapy landscape with innovative treatments for significant unmet medical needs

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