Quality Assurance Specialist

1 week ago


East Riding Of Yorkshire UK, Yorkshire And The Humber, United Kingdom AssureBio Full time

AssureBio has an exciting full-time opportunity for our client in Yorkshire who is seeking an experienced Quality Specialist. We require an individual with strong leadership skills, a proactive "can-do attitude," and a proven track record for quality and compliance. Applicants who are trainee QPs will be considered for this opportunity.


Job role


As the Quality Assurance Specialist/SME, you will lead a team responsible for maintaining and improving our quality function. You will ensure compliance with industry standards, manage the Quality Management System (QMS), and oversee the production of high-quality products that meet client requirements. The role includes:


  • Developing and enhancing QMS documents and processes for compliance.
  • Managing site-related deviations, change controls, risk assessments, and CAPAs.
  • Overseeing operations to meet standards, including validation activities.
  • Managing new product introductions (NPI) and supplier relationships.
  • Conducting internal and external audits, including competent authority inspections.
  • Training personnel and monitoring KPIs.


Essential Skills

  • 5-10 years of experience in Quality Assurance within pharmaceutical manufacturing.
  • Knowledge of Human Medicines Regulations, Medical Device Regulations, GMP, GDP, ISO 9001, and ISO 13485.
  • Proven leadership and team management skills in a quality environment.


Desirable Qualifications

  • Degree in pharmaceutical science or a related field.
  • Experience with manufacturing medicinal oral liquids, creams, and ointments.
  • Familiarity with supply chains for medicinal drug products/medical devices.
  • Training delivery and project management experience.


Personal Characteristics

  • Strong organisational skills.
  • Leadership that reflects company values and standards.


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