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Quality Assurance Operations Manager
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Quality Assurance Lead
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Wrexham, Wrexham, United Kingdom Meet Full timeAbout the RoleWe 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 ResponsibilitiesProvide expert quality guidance and solutions based on a deep understanding of GMP,...
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Experienced Quality Assurance Specialist
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Experienced Quality Assurance Specialist
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Quality Assurance Director
2 months ago
Meet is a leading biopharmaceutical company that specializes in developing innovative therapies for specialty care. Our mission is to put patients first by empowering our employees and fostering a culture of boldness, agility, and entrepreneurship.
About the RoleWe 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 Good Manufacturing Practices (GMP), Quality Risk Management (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 Subject Matter Expert (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.
- 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.
- Be part of a rapidly growing company with exciting opportunities for professional development.
- Contribute to a major multi-million investment in our 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.
