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At STADA we pursue our purpose "Caring for people's health as a trusted partner" worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.
Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson's disease. We are highly committed to improving the quality of life for People with Parkinson's disease.
Senior Quality Assurance Officer
Reading | United Kingdom (GB) | Full-time | Permanent
We are looking for a Senior Quality Assurance Officer!
How You Will Make An Impact:
* Support the GxP Quality Management System by conducting audits, managing deviations, and ensuring compliance with EU GMP and GDP standards.
* Manage supplier assurance processes, including external audits, technical agreements, and quality improvement plans.
* Oversee product release to the market, ensuring regulatory compliance and reviewing batch release documentation.
* Act as a Responsible Person (RP) and Responsible Person for Import (RPi), ensuring GDP compliance and addressing non-conformities.
* Conduct risk assessments, implement corrective and preventive actions (CAPA), and deliver training on GDP and regulatory compliance.
* Collaborate with supply chain, logistics, and warehousing teams to ensure efficiency and compliance without compromising product quality.
* Maintain accurate records, respond to regulatory inspections, and ensure continuous professional development (CPD)
What We Are Looking For:
* A degree in chemistry or a related life sciences field, with membership in a professional body (e.g., Royal Society of Chemistry/Biology/Pharmacy).
* Significant QA experience in an EU GMP and GDP-regulated environment, with knowledge of quality management systems and sterile product manufacturing.
* Proven experience as a Responsible Person (RP) or RPi on a named license, with expertise in GDP and GMP auditing.
* Strong decision-making, problem-solving, and risk management skills to address significant non-compliances.
* High attention to detail, excellent communication skills, and the ability to work effectively in a fast-paced regulatory environment.
* Solid understanding of EU regulations and guidance related to GMP and GDP, with experience advising on CAPA, deviations, and change controls.
How We Care For You:
At Britannia, our purpose "Caring for people's health as a trusted partner" motivates us every day. And what would be a better place than starting with our own colleagues. Which is why we give so much in return:
Competitive salary and annual bonus scheme.
Salary Sacrifice Pension Scheme
25 days of annual leave plus bank holidays with the potential to buy up to 5 additional days.
Health benefits provided through BUPA Private Medical Insurance.
Free winter flu jab.
Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing - offering free coaching and counselling services for you and your family.
Electric Car Scheme through Octopus Energy.
Cycle to Work Scheme.
Enhanced Family Leave.
Plus, many more colleague benefits & celebration events.
STADA Group values and promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology, or sexual orientation. We use the strength of our uniqueness to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment. We are looking forward to your application.
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