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- Tasks: Support quality activities and manage compliance in a dynamic pharmaceutical environment.
- Company: Growing pharmaceutical manufacturer in North West England.
- Benefits: Competitive package and opportunity to work with a supportive QA team.
- Other info: Fast-paced environment with opportunities for career growth.
- Why this job: Make a real impact on quality assurance in the pharmaceutical industry.
- Qualifications: Degree in a scientific discipline and experience as a Qualified Person.
The predicted salary is between 50000 - 65000 £ per year.
BioTalent are currently representing a growing pharmaceutical manufacturer based in the North West in their search for an experienced Qualified Person. You will be integral to the Quality department supporting on the week to week release activities alongside other major QA projects for the site. This position requires individuals to have prior experience working on a license and preferably with terminally sterilised products.
Key requirements:
- Review and evaluate batch records and authorise batch disposition.
- Manage the site QMS, monitor compliance with GMP and drive quality improvements.
- Review and approve deviations and laboratory investigations in compliance with GMP.
- Investigate and respond to complaints.
- Highly collaborative, regular interaction with senior management, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers and regulators.
- Ability to work independently with limited supervision, self-driven, responsive and results orientated.
Duties:
- The successful candidate will be qualified to degree level (as a minimum) in a relevant scientific discipline.
- The candidate must be eligible to act as a Qualified Person for medicinal products (as defined in EU Directive 2001/83/EC) and have been named on a UK MIA.
- Robust technical knowledge of EU GMP, regulations and guidelines.
- Experienced in the operation of an EU regulatory approved QMS.
- At least 5 years’ experience in a GMP QA role within the pharmaceutical industry and experience of managing quality systems.
- Ability to work independently with limited supervision, self-driven, responsive and results orientated.
This is an excellent opportunity for an individual who is looking to work in a fast paced, dynamic environment supported by a wider QA team. Shortlisting for this role has begun with a view to holding first stage interviews over the next couple of weeks.
For further information please contact Sarah Pawar on 0203 9115 888 or email a copy of your CV to sarah.pawar@biotalent.com.
Qualified Person employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QA. 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 your knowledge of EU GMP regulations and quality systems. We recommend practising common interview questions related to your experience as a Qualified Person to show you’re the right fit.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for tailored job listings that match your skills and aspirations in the pharmaceutical sector.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind and show your enthusiasm for the role. We believe a little courtesy goes a long way in making a lasting impression.
We think you need these skills to ace Qualified Person
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GMP and quality systems. We want to see how your background aligns with the role of a Qualified Person, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. We love seeing enthusiasm and a clear understanding of the responsibilities involved, so let your personality come through.
Showcase Your Technical Knowledge: Since this role requires robust technical knowledge of EU GMP regulations, make sure to mention any specific experiences or training you have in this area. We’re looking for candidates who can hit the ground running!
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 this exciting opportunity. Don’t miss out!
How to prepare for a job interview at BioTalent
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of EU GMP regulations and guidelines. Be prepared to discuss how you've applied these in your previous roles, especially in relation to batch records and quality systems.
✨Showcase Your Collaborative Spirit
This role requires regular interaction with various departments and stakeholders. Think of examples where you've successfully collaborated with others, particularly in a QA context, and be ready to share those stories during the interview.
✨Prepare for Technical Questions
Expect some technical questions related to your experience with terminally sterilised products and batch disposition. Review your past experiences and be ready to explain your decision-making process in those situations.
✨Demonstrate Your Problem-Solving Skills
Be ready to discuss how you've handled deviations and laboratory investigations in compliance with GMP. Prepare specific examples that highlight your ability to investigate issues and implement effective solutions.