Quality Assurance Lead

1 day ago


Wrexham, Wrexham, United Kingdom Meet Full time
About the Role:

We are seeking a highly skilled Quality Assurance Lead to join our dynamic QA Operations department. As a key member of our team, you will play a pivotal role in ensuring the highest standards of quality across our manufacturing processes.

This is a fantastic opportunity to work in a state-of-the-art facility in Wrexham, where you will oversee and support a wide range of activities, from drug substance production to biologics development, and engineering validations.

Your expertise will be integral in maintaining compliance, driving improvements, and acting as a Subject Matter Expert (SME) across the product lifecycle.

Key Responsibilities:
  • Provide expert quality guidance and solutions based on a deep understanding of GMP, QRM, and relevant manufacturing processes.
  • Lead initiatives to enhance practices and procedures, ensuring alignment with GMP requirements for sterile medicinal products.
  • Take charge of critical quality documentation, including review and approval of all drug substance release materials.
  • Liaise with leadership and cross-functional teams, providing expert opinions and contributing to key quality discussions.
  • Serve as a trusted SME within QA, offering coaching and learning opportunities to drive continuous improvement.
  • Act as a deputy for the QA Operations Process Leader when needed, ensuring seamless quality operations.
Requirements:
  • Extensive knowledge of cGMP and QRM in pharmaceutical manufacturing.
  • Exceptional organizational skills, with the ability to prioritize, manage time, and assess risk effectively.
  • A logical, process-oriented thinker with strong communication skills, capable of working collaboratively in a team.
  • Proficiency in evaluation and root cause analysis, with a track record of leading quality improvements.
  • Ability to be a point of contact for quality events and escalations, providing expert guidance and solutions.
Why Join Us?

We offer a competitive salary and an enhanced benefits package, including an annual bonus, a generous pension scheme, and wellness allowances. Join a workplace recognized as a 'Best Workplace' and 'Best Workplace for Wellbeing,' with a genuine commitment to sustainability, powered by 100% renewable energy.



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