At a Glance
- Tasks: Manage quality systems, oversee change controls, and ensure compliance in a fast-paced environment.
- Company: Join a dynamic, high-growth pharmaceutical organisation making a real impact in healthcare.
- Benefits: Enjoy a full-time role with opportunities for professional growth and development.
- Other info: Work closely with cross-functional teams and utilise electronic QMS platforms like Veeva Vault.
- Why this job: Be part of a collaborative team driving quality improvements and compliance in the pharmaceutical industry.
- Qualifications: Degree in Life Sciences or equivalent, with 3-5 years in a GxP-regulated environment required.
The predicted salary is between 28800 - 43200 £ per year.
Direct message the job poster from Blackfield Associates
Lead Quality Assurance Consultant - United Kingdom & Ireland
Blackfield are partnered with a dynamic, high-growth pharmaceutical organisation in the search for a Quality specialist based in Surrey.
The Quality Systems Specialist will play a key role in supporting the operational implementation and continuous improvement of the Quality Management System, ensuring compliance with GDP and/or GMP requirements. This role focuses on managing Change Controls, Deviations, and CAPA processes, while also contributing to other QA system activities when required. The successful candidate will act as a subject matter resource for quality event management, document control, and quality metrics, working closely with cross-functional teams to drive compliance and process improvement.
Key Responsibilities:
- Manage Change Controls as owner, overseeing risk assessments, stakeholder coordination, approvals, and closure in line with ICH Q9 principles and internal SOPs.
- Support quality event management, ensuring deviations, CAPAs, and change controls are initiated, investigated, documented, and closed within agreed timelines.
- Oversee QA-controlled documentation, including SOPs, Work Instructions, and Forms, ensuring correct lifecycle workflows, training compliance, and document control in Veeva Vault.
- Prepare and analyse Quality Metrics and KPIs for Deviation, CAPA, and Change Control processes, contributing to trend analysis, Quality Review Meetings, and Management Reviews.
The ideal candidate will hold a degree in a Life Sciences discipline (or equivalent experience) and have 3–5 years’ experience in a GxP-regulated pharmaceutical environment. They will demonstrate strong knowledge of EU GDP/GMP guidelines, experience managing quality system processes, and proficiency with electronic QMS platforms such as Veeva Vault, Q-Pulse, etc. Exceptional attention to detail, problem-solving skills, and the ability to work independently in a fast-paced environment are essential.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
Seniority level
-
Seniority level
Associate
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
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Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Transportation, Logistics, Supply Chain and Storage
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Quality Assurance Specialist employer: Blackfield Associates
Join a leading pharmaceutical company in Slough as a Scientist in Antibody Formulation Development, where you will be part of a dynamic team that plays a crucial role in advancing innovative therapies. The company fosters a collaborative work culture, offering extensive opportunities for professional growth and development, alongside competitive benefits that support work-life balance. With a focus on cutting-edge research and a commitment to employee well-being, this is an excellent opportunity for those seeking meaningful and rewarding employment in the biotechnology field.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Blackfield Associates. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Blackfield Associates.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Blackfield Associates. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Blackfield Associates is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Blackfield Associates!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Blackfield Associates that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Blackfield Associates!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Blackfield Associates, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Blackfield Associates
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Blackfield Associates that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Blackfield Associates’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
