Senior QA Officer

STADA Arzneimittel AG; Reading; On-site; GBP 45,000 - GBP 60,000; Full time

Job summary

A leading pharmaceutical company in Reading is seeking a Senior Quality Assurance Officer to support the GxP Quality Management System, ensuring compliance with EU GMP and GDP standards. Key responsibilities include conducting audits, managing supplier assurance, and overseeing product releases. Candidates should possess a degree in chemistry or equivalent, along with significant QA experience in regulated environments. The position offers competitive salary packages and various employee benefits for those looking to make a meaningful impact on health.

Benefits

Competitive salary and annual bonus

Salary Sacrifice Pension Scheme

25 days annual leave plus bank holidays

Health benefits through BUPA

Free winter flu jab

Wellbeing support services

Electric Car Scheme

Enhanced Family Leave

Qualifications

• Significant QA experience in EU GMP and GDP-regulated environment.
• Proven experience as a Responsible Person (RP) or RPi on a named license.
• Solid understanding of EU regulations related to GMP and GDP.

Responsibilities

• Support the GxP Quality Management System through audits.
• Manage supplier assurance processes and oversee product release.
• Conduct risk assessments and implement corrective actions.

Skills

Quality Assurance experience

Regulatory compliance knowledge

Problem-solving skills

Communication skills

Attention to detail

Education

Degree in chemistry or related life sciences

Membership in a professional body

Job description

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 QA Officer

We are looking for aSenior 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.

👪Enhanced Family Leave.

🎉Plus, many more colleague benefits & celebration events.

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with positive attitude, expert knowledge and an entrepreneurial spirit that enjoy friendly working environment in a global team. We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com