Quality Assurance Manager

1 week ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust Full time
Job Title: QA Validation Manager

We are seeking a highly motivated and experienced QA Validation Manager to join our Quality Assurance Team at Newcastle Specials. As a key member of our team, you will be responsible for leading the validation of analytical methods, equipment, and computerized systems in accordance with Pharmaceutical Good Manufacturing Practice (GMP) guidelines.

About the Role

The successful candidate will have a thorough understanding of GMP, a strong technical background, and excellent communication and project management skills. You will work closely with the production and business teams to ensure the delivery of projects and products for our customers, clients, and service users.

Main Responsibilities
  • Lead the validation of analytical methods, equipment, and computerized systems in accordance with GMP guidelines.
  • Develop and implement a risk-based approach to validation in accordance with our validation master plan.
  • Project manage and report on progress against targets, identifying milestones and areas that may introduce delay.
  • Train Quality Control staff and others on GMP, GDP, QA, and regulatory requirements.
  • Attend regulatory audits and provide support and direction as necessary.
Requirements
  • Masters-level qualification or equivalent experience in a relevant discipline.
  • Relevant experience of working in a licensed pharmaceutical facility.
  • Audit experience by external auditing organizations, such as the MHRA.
  • Managing or training staff.
  • Extensive theoretical and practical experience of audit and policy development.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a motivated and experienced QA Validation Manager looking for a new challenge, please apply today.



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