Quality Assurance Specialist

Are you an experienced Quality Specialist with a passion for maintaining the highest standards in pharmaceutical manufacturing? We have an exciting opportunity for you to lead our Client's quality function at their Hull site!

Quality Assurance Specialist

Location: Hull - Onsite

Employment Type: Full-time, permanent

Salary: £45,000 - £55,000 dependent on experience

Responsibilities:

• Collaborate in the development, implementation, and enhancement of Quality Management System (QMS) documents and processes to ensure compliance with quality standards.
• Maintain the Quality Management System, overseeing the preparation of all necessary technical documentation.
• Manage the site Quality Management System, leading the progression of site-related deviations, change controls, risk assessments, and corrective and preventive actions (CAPAs).
• Implement a comprehensive risk management strategy for all Good Practice (GxP) risks.
• Ensure that both business operations and the associated supply chain adhere to relevant standards, including validation activities as required.
• Oversee new product introduction (NPI) projects, ensuring they are implemented in a timely manner.
• Foster effective relationship management between the company and external partners.
• Manage supplier relationships by overseeing third-party suppliers, conducting audits, and reviewing and approving quality agreements.
• Supervise all internal and external audits, including managing inspections by competent authorities.

• Requirements:
• 5 to 10 years of experience in Quality Assurance within a pharmaceutical manufacturing environment.
• In-depth knowledge of Human Medicines Regulations, Good Manufacturing Practice, ISO 9001, and ISO 13485.
• Proven leadership skills, with experience overseeing day-to-day quality activities as well as the ability to work hands on.

Desirable skills:

• Degree-level qualification in a relevant field, preferably pharmaceutical science.
• Experience in manufacturing medicinal creams, ointments, or liquids.
• Familiarity with the supply chains of medicinal drug products and medical devices.