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- Tasks: Conduct audits, manage deviations, and ensure compliance with EU GMP and GDP standards.
- Company: STADA is a leading pharmaceutical manufacturer focused on improving health worldwide.
- Benefits: Enjoy competitive salary, annual bonus, health benefits, and flexible leave options.
- Why this job: Join a mission-driven team dedicated to enhancing the quality of life for people with Parkinson's disease.
- Qualifications: Degree in chemistry or life sciences, with significant QA experience in regulated environments.
- Other info: Embrace a diverse culture that values creativity and innovation.
The predicted salary is between 36000 - 60000 £ per year.
This job is brought to you by Jobs/Redefined, the UK\’s leading over-50s age inclusive jobs board.
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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Senior Quality Assurance Officer employer: STADA Arzneimittel AG
Contact Detail:
STADA Arzneimittel AG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Officer
✨Tip Number 1
Familiarise yourself with the specific EU GMP and GDP regulations that are relevant to the role. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in quality assurance roles. Engaging with them can provide insights into the company culture at STADA and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences as a Responsible Person (RP) or RPi. Be ready to share specific examples of how you've managed compliance issues or conducted audits, as this will highlight your suitability for the position.
✨Tip Number 4
Stay updated on the latest trends and developments in quality assurance within the pharmaceutical sector. This knowledge can be a great conversation starter during interviews and shows your proactive approach to professional development.
We think you need these skills to ace Senior Quality Assurance Officer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Senior Quality Assurance Officer position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your significant QA experience in EU GMP and GDP-regulated environments. Provide specific examples of your work as a Responsible Person (RP) or RPi, showcasing your expertise in auditing and compliance.
Showcase Your Skills: Demonstrate your strong decision-making, problem-solving, and risk management skills in your application. Use concrete examples to illustrate how you've addressed non-compliances and implemented corrective actions in previous roles.
Personalise Your Cover Letter: Craft a personalised cover letter that reflects your passion for improving the quality of life for people with chronic conditions, particularly in the neurology market. Align your values with those of STADA and express your enthusiasm for contributing to their mission.
How to prepare for a job interview at STADA Arzneimittel AG
✨Know Your Regulations
Familiarise yourself with EU GMP and GDP regulations, as well as any recent changes. Being able to discuss these in detail will show your expertise and commitment to quality assurance.
✨Demonstrate Your Experience
Prepare specific examples from your past roles that highlight your experience as a Responsible Person (RP) or RPi. Discuss how you managed audits, deviations, and compliance issues effectively.
✨Showcase Problem-Solving Skills
Be ready to discuss how you've tackled significant non-compliances in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers and demonstrate your decision-making process.
✨Emphasise Team Collaboration
Highlight your ability to work with cross-functional teams, such as supply chain and logistics. Share examples of how you've ensured compliance without compromising product quality through effective collaboration.
