Quality Assurance Lead

3 weeks 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.

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?
  • Be part of a rapidly growing company with exciting opportunities for professional development.
  • Contribute to a major multi-million investment in our Wrexham facility, expanding our capabilities and impact.
  • Work in a supportive environment with a fantastic culture and a strong commitment to Diversity & Inclusion.
  • Enjoy 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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