Senior Quality Assurance Manager

4 days ago


Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
About the Role

We are seeking a highly skilled and experienced Senior Quality Assurance Officer to join our Quality Assurance team at Mundipharma. As a key member of our team, you will be responsible for ensuring the highest standards of quality in our manufacturing operations.

Key Responsibilities
  • Quality Assurance Leadership: Provide front-line QA support to manufacturing operations, ensuring continuous compliance with GMP and company requirements.
  • Deviation Management: Advise on deviations, including containment actions and product disposition, and oversee investigations and corrective/preventive actions.
  • Quality Investigations: Lead/facilitate quality investigations to identify root causes and implement continuous improvements.
  • Compliance and Audits: Ensure compliance with QA processes and support internal and external audits.
  • Risk Management: Support the business in managing quality risks.
  • Team Support: Provide coaching and support to junior QA team members.
Requirements
  • Scientific Degree: Pharmacy, Chemistry, Biology, Engineering, or similar.
  • QA Experience: Significant practical experience in QA roles within the Pharmaceutical and/or Medical Devices Industry.
  • GMP Knowledge: Extensive knowledge and application of GMP and Pharmaceutical regulatory requirements.
  • Manufacturing Experience: Broad knowledge and experience of various manufacturing processes and equipment.
  • Internal Auditing: Internal auditing certification and experience in GxP auditing.
  • Communication Skills: Expert technical report writing skills and strong ability to communicate and interact at all levels of the business.
What We Offer
  • Flexible Benefits: A flexible benefits package.
  • Learning and Development: Opportunities for learning and development through our varied program.
  • Inclusive Environment: A collaborative, inclusive work environment.


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