Quality Assurance Specialist - Pharmaceutical Manufacturing

About the Role

Our client, a reputable pharmaceutical manufacturer based in Sunderland , is seeking a meticulous and dedicated Quality Assurance Specialist to ensure the highest standards of product quality and regulatory compliance across their operations. You will be instrumental in maintaining and improving the company's Quality Management System (QMS), conducting audits, and overseeing documentation to meet stringent industry regulations. This role is critical to our client's commitment to producing safe and effective pharmaceutical products for patients, operating within a state-of-the-art facility.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant regulations such as GMP (Good Manufacturing Practice).
• Conduct internal audits of manufacturing processes, documentation, and facilities to identify areas for improvement and ensure compliance.
• Review and approve critical quality-related documents, including batch records, validation protocols, and standard operating procedures (SOPs).
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs) to prevent recurrence.
• Participate in external audits and inspections by regulatory authorities, providing necessary documentation and support.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical manufacturing industry.
• In-depth knowledge of GMP regulations and quality systems.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Proficiency in using quality management software and standard office applications.

Benefits

• Competitive salary and annual bonus opportunities.
• Comprehensive health, dental, and vision insurance coverage.
• Generous pension contributions and life assurance.
• Paid time off and company holidays.
• Continuous training and professional development programs to enhance skills in pharmaceutical quality assurance.