At a Glance
- Tasks: Ensure compliance with GMP and support continuous improvement in a dynamic environment.
- Company: Join an exciting pharmaceutical company based in London, making a real impact in healthcare.
- Benefits: Enjoy a collaborative culture with opportunities for professional growth and development.
- Other info: Ideal for those looking to make a difference in the pharmaceutical industry.
- Why this job: Be part of a team that values quality and innovation, contributing to essential healthcare solutions.
- Qualifications: Previous hands-on experience with GMP and a solid understanding of regulatory guidelines required.
The predicted salary is between 36000 - 60000 £ per year.
Walker Cole International is supporting a well-established pharmaceutical wholesale distribution organisation in the search for a Quality Specialist to join their Quality team, based in Kent.
This is an excellent opportunity to join a GDP-regulated environment, working closely with the Responsible Person (RP) to ensure products are stored and distributed safely and in full compliance with EU GDP and HPRA requirements. The role offers broad, hands‑on exposure across quality systems, complaints and deviations, supplier approval, self‑inspections, training and regulatory inspections.
This role would suit a QA professional with at least one year’s quality experience who is looking to build their GDP expertise, with the opportunity to deputise for the RP.
You will be responsible for:
- Ensuring compliance with the Wholesale Distribution Authorisation, EU GDP Guidelines 2013/C 343/01 and HPRA requirements.
- Handling and escalating complaints, returns, deviations, CAPAs and change controls, ensuring they are recorded, investigated and closed in a timely manner.
- Managing supplier and customer approval processes and maintaining the approved lists.
- Managing SOPs, including implementing new procedures, tracking implementation and supporting annual documentation reviews.
- Maintaining the training matrix and delivering GDP and SOP training to staff.
- Preparing EU batch review documents for RP approval and release.
- Supporting the RP with product recalls, mock recalls, and the management of quarantined, returned, rejected and falsified medicines.
- Supporting preparation for, and participating in, regulatory and customer inspections and self‑inspections.
- Collating quality KPIs and trends for Quality Management Review meetings.
- Supporting the monitoring and updating of Quality Agreements, and participating in risk assessments.
The successful candidate will have:
- At least one year’s experience working in a quality department within the pharmaceutical industry.
- A good understanding of EU GDP guidelines and HPRA requirements.
- Experience handling deviations, CAPAs, change controls, complaints or returns.
- Experience with SOPs, document control and training records.
- Strong attention to detail, with excellent communication and organisational skills.
- The ability to work collaboratively across departments, with a proactive approach to continuous improvement.
Quality Specialist | Quality Assurance | QA | GDP | Good Distribution Practice | EU GDP | HPRA | Responsible Person | RP | Wholesale Distribution | WDA | Deviations | CAPA | Change Control | Supplier Approval | Self-Inspection | Recalls | Pharmaceutical
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Quality Assurance Specialist employer: WALKER COLE INTERNATIONAL LTD
Walker Cole International is an exceptional employer, offering a dynamic work environment where innovation and continuous improvement are at the forefront. As a QA Operations Manager, you will benefit from a culture that prioritises employee development through training and mentorship, while also enjoying the unique advantage of working in a leading manufacturing facility that values operational excellence. With a commitment to performance excellence and collaboration across teams, this role provides meaningful opportunities for professional growth and impactful contributions to the organisation's success.
Contact Details:
WALKER COLE INTERNATIONAL LTD Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practice (GMP) guidelines and regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in quality assurance roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to continuous improvement in previous roles. Highlighting your proactive approach to quality assurance will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest regulatory changes from the MHRA and other relevant bodies. Showing that you are informed about current guidelines will reflect your dedication to the field and enhance your candidacy.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Understand the Role:Read the job description thoroughly to understand the key responsibilities and required skills for the Quality Assurance Specialist position. Tailor your application to highlight your relevant experience in GMP and regulatory guidelines.
Highlight Relevant Experience:In your CV and cover letter, emphasise your hands-on experience with Good Manufacturing Practice (GMP) and any previous roles that demonstrate your ability to work cross-functionally. Use specific examples to showcase your achievements.
Showcase Continuous Improvement Skills:Mention any initiatives or projects where you contributed to continuous improvement in quality assurance processes. This will demonstrate your proactive approach and alignment with the company's goals.
Proofread Your Application:Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Assurance Specialist.
How to prepare for a job interview at WALKER COLE INTERNATIONAL LTD
✨Brush Up on GMP Knowledge
Make sure you have a solid understanding of Good Manufacturing Practice (GMP) and can discuss how you've applied it in your previous roles. Be ready to provide specific examples of how you ensured compliance.
✨Showcase Continuous Improvement Initiatives
Prepare to talk about any initiatives you've led or contributed to that drove continuous improvement in quality assurance processes. Highlight your problem-solving skills and how they benefited your previous employers.
✨Understand Regulatory Guidelines
Familiarise yourself with the regulatory guidelines set by the MHRA. Be prepared to discuss how these regulations impact quality assurance and how you've navigated them in past positions.
✨Demonstrate Cross-Functional Collaboration
Think of examples where you've worked cross-functionally with other departments. Emphasise your communication skills and how you effectively collaborated to achieve common goals in quality assurance.
