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- Tasks: Ensure life-changing medicines meet safety and compliance standards through detailed quality checks.
- Company: Leading global biopharmaceutical organisation with a focus on innovation.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Why this job: Make a real impact in healthcare by ensuring the quality of groundbreaking therapies.
- Qualifications: Degree in a scientific field; QA experience preferred but not essential for passionate graduates.
- Other info: Collaborate with global teams in a fast-paced setting, perfect for detail-oriented problem solvers.
The predicted salary is between 36000 - 60000 £ per year.
Exciting opportunity has arisen for an experienced Quality Assurance (QA) professional to join a leading global biopharmaceutical organisation within their Global Development Quality group. In this pivotal role, you’ll be exposed to a wide range of investigational medicinal products - from small molecules to advanced immunotherapies - playing a key part in ensuring these life-changing medicines reach patients safely and compliantly.
As a Quality Specialist, you will be responsible for the final review of clinical batch records, ensuring GMP compliance and alignment with regulatory filings. You’ll compile and approve data packs for presentation to the Qualified Person (QP) for final release, collaborating closely with global teams across the clinical supply chain and manufacturing sites worldwide. This position offers the chance to work independently in a dynamic, fast-paced environment where attention to detail, strong communication, and problem-solving skills are essential.
Key Responsibilities- Review clinical batch records and supporting documentation to ensure compliance with GMP and regulatory standards.
- Compile and approve data packs for QP release of clinical trial materials.
- Conduct or support audits of data, processes, systems, and facilities to ensure ongoing GMP compliance.
- Review and approve production and analytical documentation for product release.
- Communicate audit findings, issue reports, and support remedial actions with relevant departments.
- Collaborate with internal and external global teams to maintain compliance and support the clinical supply chain.
- Experience in pharmaceutical, biotech, or regulatory agency QA roles with a solid understanding of cGMP regulations.
- Strong attention to detail with excellent written and verbal communication skills.
- Ability to work independently and manage issue resolution effectively.
- Skilled in documentation review, audit preparation, and regulatory compliance.
- Bachelor’s degree or higher in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
- Prior QA or GMP experience preferred, but applications are also welcomed from ambitious science graduates with a strong desire to develop in a pharmaceutical quality environment.
Quality Assurance Specialist employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the biopharmaceutical field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Quality Assurance Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and understanding of clinical batch records. We recommend practising common interview questions related to QA and having examples ready to showcase your problem-solving skills.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for tailored job listings that match your expertise in QA and GMP compliance.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We believe it shows your enthusiasm for the role and keeps you fresh in the interviewer's mind.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance role. Highlight your experience in pharmaceutical or biotech QA roles, and don’t forget to mention any specific knowledge of cGMP regulations. 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 quality assurance and how your skills can contribute to our mission. Be sure to mention any relevant experiences that showcase your attention to detail and problem-solving abilities.
Showcase Your Communication Skills: As a Quality Specialist, strong communication is key. In your application, demonstrate your ability to convey complex information clearly. Whether it’s through your CV or cover letter, make sure we can see your written communication skills in action!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Planet Pharma
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practice (GMP) regulations before the interview. Being able to discuss specific examples of how you've ensured compliance in past roles will show your expertise and commitment to quality.
✨Showcase Your Attention to Detail
Prepare to give examples that highlight your attention to detail. Whether it’s a project where you caught a critical error or a time you meticulously reviewed documentation, these stories will demonstrate your fit for the role.
✨Communicate Clearly and Confidently
Since strong communication skills are essential, practice articulating your thoughts clearly. You might be asked to explain complex concepts, so being concise and confident will help you stand out.
✨Collaborate and Problem-Solve
Be ready to discuss how you've worked with global teams in the past. Share specific instances where you resolved issues collaboratively, as this will showcase your ability to thrive in a dynamic environment.