Hybrid working (up to 3 days per week onsite in Berkshire)
About the Role
We are seeking a Quality Specialist to support the maintenance and continuous improvement of the Quality Management System and ensure compliance with applicable GxP requirements.
Key Responsibilities
- Manage and maintain quality records, including Deviations, Change Controls, Complaints and CAPAs.
- Provide Quality support and guidance to cross-functional stakeholders across GxP activities.
- Identify quality risks and improvement opportunities and support appropriate corrective actions.
- Monitor and trend quality metrics and support Management Reviews.
- Coordinate Annual Product Quality Reviews and local stability programmes.
- Maintain Quality training curricula and ensure appropriate training is completed and effective.
- Support product traceability, returns, recalls and falsified product processes.
- Support self-inspections, audits, regulatory inspection readiness and follow-up actions.
- Oversee local vendors, including qualification, Quality Agreements, audits and ongoing monitoring.
- Support customer and supplier qualification activities.
- Ensure GxP documentation is accurately maintained within electronic quality systems.
About You
- Bachelor’s degree in Life Sciences, such as Biology, Chemistry or Pharmacy.
- Ideally 5+ years’ experience in a pharmaceutical Quality role.
- GDP experience is advantageous.
- Strong organisational, communication and problem-solving skills.
- Ability to work independently and collaboratively.
- Excellent attention to detail and ability to manage complex situations.
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Quality Specialist in Slough employer: Warman O'Brien
Join a leading global biotech organisation that is at the forefront of Oncology innovation, where your expertise as a Senior Medical Science Liaison will be valued and impactful. With a hybrid work model, you will enjoy a flexible work-life balance while being part of a collaborative culture that prioritises employee growth and development through continuous learning opportunities. This role not only offers competitive benefits but also the chance to contribute to groundbreaking advancements in healthcare, making it a truly rewarding career choice.
