Job Description
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.