Senior Quality Assurance Manager

1 week ago


Hull, Kingston upon Hull, United Kingdom Advanced Resource Managers Full time
Job Description

We are seeking a highly experienced Senior Quality Assurance Manager to lead our Client's quality function at their Hull site.

This is an exciting opportunity to join Advanced Resource Managers and contribute to the development, implementation, and enhancement of Quality Management System (QMS) documents and processes.

The successful candidate will oversee the preparation of all necessary technical documentation, manage site-related deviations, change controls, risk assessments, and corrective and preventive actions (CAPAs).

Key responsibilities include:

  • Implementing a comprehensive risk management strategy for all Good Practice (GxP) risks.
  • Ensuring that both business operations and the associated supply chain adhere to relevant standards, including validation activities as required.
  • Overseeing new product introduction (NPI) projects, ensuring they are implemented in a timely manner.
  • Fostering effective relationship management between the company and external partners.
  • Managing supplier relationships by overseeing third-party suppliers, conducting audits, and reviewing and approving quality agreements.
  • Supervising 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.


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