Job Description
Job Title: Qualified Person (QP)
Location: Oxford, England
Employment Type: Permanent
Job Description:
An exciting opportunity has arisen for a Qualified Person (QP) to join our client’s Quality team based in Oxford. This role is pivotal in ensuring the batch certification, regulatory compliance, and quality assurance of sterile pharmaceutical products, adhering to Good Manufacturing Practice (GMP).
Key Responsibilities:
* Perform duties as a Qualified Person (QP) under EU GMP regulations for the release of sterile products.
* Ensure full regulatory compliance with MHRA, EU GMP, and company policies.
* Oversee and enhance Quality Management Systems (QMS) to ensure continuous improvement.
* Manage deviations, CAPA, change controls, and regulatory audits to maintain high-quality standards.
* Work closely with manufacturing, regulatory, and supply chain teams to ensure smooth and compliant operations.
* Provide quality leadership, guidance, and training to the team to uphold GMP compliance.
* Keep up to date with regulatory developments and ensure best practices are implemented.
Key Requirements:
* Legally recognized as a Qualified Person (QP) under EU Directive 2001/83/EC.
* Demonstrable experience in sterile manufacturing and batch release.
* Strong understanding of GMP, QMS, regulatory compliance, and pharmaceutical quality assurance.
* Ability to manage regulatory inspections, audits, and continuous quality improvement initiatives.
* Excellent problem-solving, communication, and leadership skills.