Quality Assurance Specialist

Advanced Resource Managers • City of Kingston upon Hull, ENG, United Kingdom • 2w ago

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.