Quality Assurance Specialist - Pharmaceuticals

About the Role

Our client is seeking a detail-oriented and proactive Quality Assurance Specialist to join their manufacturing facility in Sunderland . This critical role ensures that all pharmaceutical products manufactured meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements. You will play a key part in maintaining and improving the quality management system, conducting audits, and investigating deviations to uphold our client's commitment to excellence. This is an ideal opportunity for a quality professional looking to make a significant impact within the pharmaceutical industry in Tyne and Wear , contributing to the production of vital medicines.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and regulatory standards.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Review and approve batch records, validation reports, and other quality-related documentation.
• Participate in external regulatory inspections and customer audits, acting as a key point of contact.
• Provide training to staff on quality procedures, GMP principles, and regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Proven experience in a Quality Assurance or Quality Control role within the pharmaceutical or related industry.
• Strong understanding of Good Manufacturing Practices (GMP), regulatory guidelines (e.g., MHRA), and quality systems.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in conducting audits, investigating deviations, and managing CAPAs.
• Strong documentation and communication skills, with meticulous attention to detail.

Benefits

• Competitive salary and benefits package.
• Opportunity to work with a leading pharmaceutical manufacturer.
• Professional development and training programs.
• Pension scheme and life assurance.
• A supportive work environment focused on continuous improvement.