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- Tasks: Ensure quality standards in pharmaceutical products and manage quality-related activities.
- Company: Join Clinigen, a fast-growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, pension contributions, and flexible benefits.
- Other info: Dynamic role with opportunities for growth and recognition.
- Why this job: Make a real impact on healthcare by ensuring product quality and compliance.
- Qualifications: Degree in Life Sciences or equivalent experience in Quality Assurance.
The predicted salary is between 36000 - 60000 £ per year.
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa.
As a Quality Specialist within the Commercial Products Quality Assurance team, you will support the ongoing maintenance and operation of the Pharmaceutical Quality System (PQS). You will coordinate quality-related tasks and activities across internal teams and external partners, ensuring robust oversight of Clinigen Marketing Authorisation Holder (MAH) responsibilities. This role has a strong focus on maintaining GxP standards, regulatory compliance, and high-quality processes to ensure the safe and effective management of commercial products.
Key Responsibilities
- Maintain and comply with Quality System requirements, including following and enforcing SOPs, job aids, company policies and GxP/GMP standards.
- Manage core Quality Management System processes for Commercial Products, such as change controls, non-conformances, quality complaints, and related documentation.
- Create, review and approve quality documentation, including SOPs, work instructions, forms, technical reports, and quality records (electronic and paper).
- Act as a Subject Matter Expert (SME) by supporting batch review and release, Annual Product Quality Reviews, Quality Technical Agreements, and investigations with internal and external stakeholders.
- Liaise with and oversee Contract Manufacturing Organisations (CMOs) through documentation review, meetings, stability programme coordination, and issue resolution.
- Support audits and inspections, including internal audits, external audits, and client or competent authority inspections.
- Contribute to continuous improvement and business projects, including providing training, influencing decisions, problem-solving, and completing additional duties to support ongoing operations.
Requirements
- Life Science (or allied discipline) degree or equivalent experience/education.
- Experience of working within the pharmaceutical / healthcare / life sciences industry in a Quality Assurance function.
- Experience of working to the standards and requirements of Good Manufacturing Practice (GMP).
- Previous experience in the management of outsourced activities and/or the management of CMOs in a pharmaceutical setting is advantageous.
- Strong organisational skills.
- Strong interpersonal, collaboration and communication skills, across all seniority levels.
- Able to promote GMP principles across Clinigen departments.
- Excellent attention to detail.
- Able to effectively multitask and prioritise a dynamic workload within defined deadlines.
- Self-motivated and tenacious in pursuit of objectives.
- Strong Computer Literacy (Word, Excel, PowerPoint, SharePoint, Outlook, eQMS).
Benefits
- 27 days holiday plus 8 bank holidays.
- Pension contributions – 4.5% matched.
- Life assurance – 4x annual salary.
- Flexible Benefits Platform with £25/month Company contribution.
- Annual salary review.
- Independent financial advice service.
- Enhanced Employee Assistance Programme.
- Shopping discounts with retailers.
- Long service awards.
- Recognition scheme & employee of the year awards.
Quality Specialist in Burton upon Trent employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist in Burton upon Trent
✨Tip Number 1
Network like a pro! Reach out to people in the pharmaceutical industry, especially those working in quality assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on GxP and GMP standards. We want you to show off your knowledge and passion for quality assurance. Practise common interview questions and have examples ready that highlight your experience.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for openings at Clinigen and tailor your approach to fit their culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. It shows your enthusiasm for the role and gives you another chance to reiterate why you’re the perfect fit for the Quality Specialist position.
We think you need these skills to ace Quality Specialist in Burton upon Trent
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Specialist role. Highlight your experience in Quality Assurance and any relevant skills that match the job description. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the pharmaceutical industry and how you can contribute to our team at Clinigen. Keep it engaging and personal!
Showcase Your Attention to Detail: As a Quality Specialist, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best work right from the start!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Clinigen
✨Know Your GxP Standards
Make sure you brush up on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. Be ready to discuss how you've applied these principles in your previous roles, as this will show your understanding of the quality assurance landscape.
✨Showcase Your Organisational Skills
Prepare examples that highlight your strong organisational skills. Think about times when you managed multiple quality-related tasks or projects simultaneously and how you prioritised them effectively. This will demonstrate your ability to handle the dynamic workload expected in this role.
✨Be a Team Player
Clinigen values collaboration, so be prepared to talk about your experience working with cross-functional teams. Share specific instances where you liaised with internal and external stakeholders to resolve issues or improve processes, showcasing your interpersonal skills.
✨Prepare for Technical Questions
Expect questions related to quality documentation and processes, such as SOPs and quality complaints. Familiarise yourself with the types of documents you might encounter and be ready to discuss how you would approach creating or reviewing them. This will highlight your expertise as a Subject Matter Expert.