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- Tasks: Ensure quality assurance in biotech manufacturing and support compliance activities.
- Company: Vertex Pharmaceuticals, a leader in transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Why this job: Join a pioneering biotech firm and make a real difference in patients' lives.
- Qualifications: Degree in biotech/life sciences and experience in GMP quality assurance.
- Other info: Collaborative environment with a focus on innovation and compliance.
The predicted salary is between 48000 - 72000 £ per year.
Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid, 3 days on site in Paddington, London
Department: Operational Area Quality
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
General Summary: This role is recognized as an expert internally in the principles and application of quality assurance and compliance. The person will provide QA support for manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will be primarily focused on batch record review, archival & support activities related to product disposition activities.
Key Duties & Responsibilities:
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Support in archiving activities.
- Support QA execution of process and OOS investigations, and associated CAPAs.
- Support for approval of COAs and product labelling.
- Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
- Support GMP release of incoming raw material and components.
- Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
- Responsible for identifying compliance risks and gaps for GMP processes.
- Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting.
- Support Cell & Genetic Program and Quality projects including Quality system, and manufacturing process/SOP improvements.
Required Knowledge/Skills:
- Bachelor's degree in biotech/life sciences field.
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
- Demonstrated experience in batch review/batch disposition of sterile products, biologic products and/or ATMPs.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA.
- Experience with network-based applications such as Oracle, TrackWise, Veeva.
- Understanding of regulatory environment including quality systems and compliance.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach.
- Ability to facilitate cross-functional meetings/projects and effectively communicate with business stakeholders.
- Critical Thinking and Problem-Solving skills.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
GMP Operational Quality Senior Specialist in London employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Operational Quality Senior Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the biotech and life sciences field, especially those who work at Vertex or similar companies. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and compliance standards. Be ready to discuss your experience with batch record reviews and CAPA processes, as these are key to impressing the hiring team.
✨Tip Number 3
Showcase your problem-solving skills! Think of examples where you've tackled quality assurance challenges. This will demonstrate your critical thinking abilities and how you can add value to their operations.
✨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 take that extra step to connect with us directly.
We think you need these skills to ace GMP Operational Quality Senior Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GMP and quality assurance. We want to see how your skills align with the role, 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 passionate about quality assurance in biotech and how you can contribute to Vertex’s mission. Keep it concise but impactful!
Showcase Your Problem-Solving Skills: In your application, mention specific examples where you've successfully tackled compliance issues or led investigations. We love seeing critical thinking in action, so let us know how you approach challenges!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. We can’t wait to hear from you!
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Understand the principles and applications of quality assurance and compliance, especially as they relate to batch record review and product disposition. Being able to discuss specific examples from your experience will show that you're not just familiar with the concepts but can apply them effectively.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you've handled past situations, particularly around event investigations and CAPA. Think of specific instances where you identified compliance risks or led a root cause analysis. Practising these scenarios will help you articulate your thought process and problem-solving skills during the interview.
✨Familiarise Yourself with Relevant Tools
Since the role involves using network-based applications like Oracle, TrackWise, and Veeva, it’s a good idea to get comfortable with these tools if you haven't already. Even if you haven’t used them directly, understanding their purpose and functionality can give you an edge in the interview.
✨Showcase Your Communication Skills
This position requires effective communication with various stakeholders. Be ready to discuss how you've facilitated cross-functional meetings or projects in the past. Highlighting your ability to communicate complex quality matters clearly will demonstrate that you can bridge gaps between teams and drive compliance effectively.
