Job Title: Qualified Person (QP)

Location: Stoke-on-Trent

Employment Type: Permanent

Job Description:

We are seeking an experienced Qualified Person (QP) to join our client's Quality team in Stoke-on-Trent. This role is critical in ensuring the compliance, release, and quality assurance of sterile pharmaceutical products in accordance with Good Manufacturing Practice (GMP).

Key Responsibilities:

• Act as a Qualified Person (QP) under EU GMP regulations for the certification and batch release of sterile medicinal products.
• Ensure strict compliance with GMP, MHRA, and EU regulations.
• Oversee Quality Management Systems (QMS) and ensure continuous improvement in quality assurance processes.
• Conduct audits, risk assessments, and deviation investigations to maintain high product quality and regulatory compliance.
• Collaborate cross-functionally with production, regulatory, and R&D teams to ensure quality standards are met.
• Provide leadership and training to the QA team to enhance compliance and operational efficiency.
• Stay updated with regulatory changes and implement necessary updates within the quality framework.

Key Requirements:

• Legally eligible to act as a Qualified Person (QP) under EU Directive 2001/83/EC.
• Strong experience in sterile manufacturing environments.
• In-depth knowledge of GMP, QMS, CAPA, and regulatory requirements.
• Proven ability to manage quality assurance processes, audits, and regulatory inspections.
• Excellent problem-solving and decision-making skills.
• Strong communication and leadership abilities.