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Senior Quality Assurance Manager

2 months ago

Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Job Summary

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

Key Responsibilities
  • Proactively conduct walkabouts to ensure compliance with GMP and company requirements, providing QA guidance as needed.
  • Advise on deviations, including containment actions and product disposition, and oversee investigations and corrective/preventive actions.
  • Lead/facilitate quality investigations to identify root causes and implement continuous improvements.
  • Contribute to maintaining compliance in all aspects of QA processes in support of our inspection readiness and compliance programs.
  • Lead or support internal audits and external audits of suppliers and third parties.
  • Support the business in managing risk to quality and provide coaching and support to junior QA team members.
Requirements
  • Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or similar, or aligned working experience.
  • Significant practical experience in QA roles within the Pharmaceutical and/or Medical Devices Industry.
  • Extensive knowledge and application of GMP and Pharmaceutical regulatory requirements.
  • Broad knowledge and experience of various manufacturing processes and equipment.
  • Previous oral solid dose experience or experience with tablets and capsules is beneficial.
  • Solid knowledge of Critical Quality Attributes of solid dose products.
  • Internal auditing certification and solid experience in GxP auditing.
  • Experience in supporting external audits by customers and competent authorities.
  • Expert technical report writing skills and strong ability to communicate and interact at all levels of the business and externally.
What We Offer
  • A flexible benefits package.
  • Opportunities for learning and development through our varied program.
  • A collaborative, inclusive work environment.