Quality Assurance Specialist - GMP Compliance

About the Role

Our client is seeking a meticulous and experienced Quality Assurance Specialist to ensure adherence to Good Manufacturing Practice (GMP) standards for their pharmaceutical operations in Leeds . You will be responsible for maintaining and improving the Quality Management System (QMS), conducting internal audits, and supporting regulatory inspections. Your expertise will be critical in upholding the highest standards of product quality and patient safety throughout the manufacturing process. This role offers a rewarding career within a company committed to excellence and continuous improvement in the pharmaceutical manufacturing sector.

Key Responsibilities

• Implement and maintain the Quality Management System (QMS) in accordance with GMP guidelines and regulatory requirements.
• Conduct internal audits of manufacturing processes, documentation, and facilities to identify deviations and areas for improvement.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, CAPAs (Corrective and Preventive Actions), and Out-of-Specification (OOS) results, ensuring timely and effective resolution.
• Support external regulatory inspections (e.g., MHRA) and customer audits.
• Provide training to manufacturing and quality personnel on GMP principles and quality procedures.

Requirements

• Bachelor's degree in a relevant scientific field (e.g., Chemistry, Pharmacy, Biology).
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or related industry, with a strong focus on GMP compliance .
• Thorough understanding of GMP regulations and guidelines applicable to pharmaceutical manufacturing.
• Experience with QMS implementation, internal auditing, and deviation management.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Effective written and verbal communication skills.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Generous annual leave and company-sponsored pension scheme.
• Opportunities for professional development and further training in quality systems.
• A supportive work environment with a focus on quality and collaboration.