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- Tasks: Ensure sterility in manufacturing and promote compliance with industry standards.
- Company: Join a leading pharmaceutical company dedicated to quality and innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and product quality in a dynamic environment.
- Qualifications: 3 years in pharma, 2 years in sterile manufacturing, strong communication skills.
- Other info: Collaborative team culture with a focus on continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking a Sterility Assurance Officer to provide expert sterility assurance guidance across manufacturing, production and engineering operations at two sterile manufacturing facilities. This role plays a key part in promoting strong aseptic behaviours, supporting GMP compliance, and driving continuous improvement within sterile operations, including support for IMP manufacture.
Key Responsibilities
- Promote and support compliance with GMP and GDP in line with current regulations and internal quality standards
- Provide sterility assurance support for manufacturing, production and engineering activities
- Carry out compliance spot checks in operational areas, including CCTV review where applicable
- Train, support and raise standards around aseptic behaviours within sterile operations
- Champion good aseptic practices essential for the manufacture of sterile pharmaceutical products
- Lead and support non conformance, complaint and OOX investigations, including GEMBA activities and report writing
- Support CAPA and change control actions
- Contribute to risk assessments and quality risk management activities
- Support and drive improvements to the site sterility assurance programme
- Compile and present environmental monitoring trend data across relevant forums
- Support self inspections and internal audits within the operational areas
- Share quality metrics relevant to sterile manufacturing activities
- Support shutdowns, new equipment introductions and validation activities, providing GxP and sterility assurance guidance
- Effectively prioritise and manage workload to meet operational and customer requirements
- Support the maintenance of up to date training records across the site
- Maintain current knowledge of industry best practice and regulatory expectations
- Apply good manufacturing principles across all areas of responsibility
- Comply with company policies, procedures, health and safety requirements, and the code of conduct
Minimum Qualifications and Experience
- Minimum of 3 years experience within pharmaceutical manufacturing, testing or quality assurance
- At least 2 years experience working in a sterile manufacturing environment
- Experience leading or contributing to quality improvement initiatives
- Strong understanding of GxP regulations and guidance
- Excellent written and verbal communication skills
- Strong stakeholder management skills with the ability to build credibility and influence
- Competent in Microsoft Word and Excel, including data handling and reporting
- Strong report writing capability
Preferred Qualifications and Experience
- Relevant scientific degree
- Strong scientific and technical understanding of sterile and aseptic manufacturing
- Experience with sterility assurance controls and contamination control strategies
- Familiarity with electronic quality management systems
- Strong organisational skills with high attention to detail
- Ability to work effectively both independently and as part of a team
Work Conditions
- Site based role
Sterility Assurance Officer in Brighton employer: Nexia
Contact Detail:
Nexia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Officer in Brighton
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical industry, especially those involved in sterility assurance. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your GxP knowledge and aseptic practices. We recommend doing mock interviews with friends or using online platforms to get comfortable discussing your experience and how it relates to the role.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your achievements in quality improvement initiatives and compliance checks. This can be a great conversation starter during interviews and sets you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Sterility Assurance Officer in Brighton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sterility Assurance Officer role. Highlight your experience in pharmaceutical manufacturing and any specific skills related to GMP compliance and aseptic practices. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about sterility assurance and how you can contribute to our team. Be sure to mention any relevant projects or achievements that showcase your expertise.
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and concise. Use proper formatting and check for any typos or grammatical errors. We appreciate attention to detail, so let that shine through!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about StudySmarter and what we stand for!
How to prepare for a job interview at Nexia
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Be ready to discuss how you've applied these in your previous roles, especially in sterile environments. This shows you’re not just familiar with the regulations but can also implement them effectively.
✨Showcase Your Aseptic Expertise
Prepare examples of how you've promoted aseptic behaviours in past positions. Think about specific situations where you trained others or improved practices. This will demonstrate your hands-on experience and commitment to maintaining high standards in sterile operations.
✨Be Ready for Compliance Spot Checks
Expect questions about compliance spot checks and how you would approach them. Have a few scenarios in mind where you identified non-conformances and how you addressed them. This will highlight your proactive attitude towards quality assurance.
✨Communicate Clearly and Confidently
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Prepare to discuss your report writing experience and how you’ve communicated complex information to stakeholders. Confidence in your communication can set you apart from other candidates.
