QA Team Leader

5 months ago


Irvine, United Kingdom Merck KGaA Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

**Your role**:
An exciting opportunity has arisen for an experienced Quality Assurance Team Leader to join the team at Irvine as a core member of the Quality leadership team, reporting to the site Head of Quality. In your role as QA Team Leader you are responsible for leading a team of 9 direct reports who are responsible for a variety of tasks such as approval of Batch Manufacturing Records, creation of label templates, maintenance of SAP master data including inspection plans and Certificate of Analysis profiles, implementation of the site Change Control management processes and implementation of the electronic document management system. You will also be expected to identify and lead Continuous Improvement initiatives relating to overall quality of product and process efficiencies.

**Who you are**:

- Bachelors or Masters degree preferably in one of the biological, life or chemical sciences
- Minimum five years of practical experience of working within Quality Management Systems in a similar role within a GMP environment is essential, complemented by the associated Quality Assurance knowledge
- Minimum two years of QA Supervisory experience and proven leadership track record
- Working knowledge of ISO9001:2015, IPEC or EXCiPACT, EU Guidance on Good Manufacturing Practice (Orange Guide), EP/USP, aseptic processing, and change management preferred
- Excellent communicator with high level of attention to detail Knowledge of cell culture products and their applica tions is preferred but not essential

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress


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