At a Glance
- Tasks: Oversee quality initiatives and ensure compliance in a dynamic biotech environment.
- Company: Vertex Pharmaceuticals, a leader in transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Fast-paced environment with strong potential for career advancement.
- Why this job: Join a team making a real impact on patients' lives through innovative science.
- Qualifications: Relevant science degree and experience in GMP/GDP and batch release.
The predicted salary is between 50000 - 60000 £ per year.
Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid, 3 days on site in Paddington, London (Two days working from home)
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.
The GMP Operational Quality Senior Specialist works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function. The Senior Specialist completes work in a resourceful, self-sufficient manner and can design alternative approaches to achieve desired outcomes. They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.
Key Responsibilities:- Perform disposition activities for Finished Goods in support of Clinical/Commercial Product, including:
- Master and Executed Batch Record review and resolution of comments/issues.
- Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status.
- Status change in Oracle.
- Provide quality guidance and oversight for Exemption Management related queries.
- QMS records review and approval (Deviation, CAPAs, Change Controls).
- Artwork Review and Approval including Bill of Materials.
- Archiving of batch documents in electronic document system.
- Collaborative reviewer of internal procedures.
- Review and approval of CMO related documents.
- Support quality oversight of artwork/label review, approval, & implementation.
- Provides quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
- Provide quality support for planning of product launches and tracking of new artworks.
- Assist in packaging validation activities as needed.
- Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and assist with ongoing relationships.
- QP Relationship and Release:
- Facilitate Disposition of QP Release of finished goods.
- Assist with QP Declaration requests.
- Collaborative reviewer of internal procedures.
- Establishment of Quality Processes/Process Ownership – Packaging /Labeling and QP Release of Finished Goods.
- Serve as review/approver or owner of deviations.
- Monitors and trends events and identifies/proposes corrective actions.
- Serve as CAPA and Deviation owner.
- Identifies risks and communicates gaps to management.
- Assists with the generation of process related metrics/monitors for efficiency.
- Commercial Change Control.
- Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy.
- Maintain batch disposition spreadsheets, input data and extract metrics.
- Relevant science degree.
- Knowledge of global GMP/GDP requirements governing oral drug products including exemption management and non-licence supply.
- Batch release experience is required.
- Knowledge of packaging and labelling process and artwork requirements.
- Investigation and Root Cause Analysis tools/methodology.
- Working with external CMOs is preferred.
- Audit process understanding.
- Ability to assess when to escalate urgent requests.
- Ability to take ownership and accountability for shared information.
- Good communication skills and ability to engage with internal and external stakeholders.
- Demonstrated ability to work independently to provide QA support for relevant projects.
- Skilled in creating and maintaining spreadsheets in Excel, including the use of formulas and macros.
- Able to adapt in a fast-paced environment.
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, 12-month contract in Slough employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking meaningful work in the biotechnology sector. With a hybrid working model based in vibrant Paddington, London, employees benefit from a supportive environment that encourages personal growth and development, alongside competitive remuneration and comprehensive benefits. The company’s commitment to scientific advancement and transformative medicine ensures that every team member plays a vital role in making a real impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land GMP Operational Quality Senior Specialist, 12-month contract in Slough
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Vertex Pharmaceuticals who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Vertex Pharmaceuticals, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace GMP Operational Quality Senior Specialist, 12-month contract in Slough
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Vertex Pharmaceuticals as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Vertex Pharmaceuticals.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Vertex Pharmaceuticals. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Vertex Pharmaceuticals.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Vertex Pharmaceuticals aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
