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For Companies At a Glance
- Tasks: Manage quality activities to ensure compliance with GMP and GDP for medicinal products.
- Company: Join a global pharmaceutical organization dedicated to quality and regulatory excellence.
- Benefits: Enjoy opportunities for continuous improvement and professional growth in a dynamic environment.
- Why this job: Be part of a mission-driven team that impacts health and safety globally.
- Qualifications: Bachelor’s degree in relevant fields and 5 years of experience in Quality Assurance required.
- Other info: Certifications in GMP and GDP are a plus; previous audit exposure is desirable.
The predicted salary is between 36000 - 60000 £ per year.
Your New Company:
A global pharmaceutical organisation committed to ensuring the highest standards of quality and compliance in the commercialisation of medicinal products. This company is dedicated to continuous improvement and regulatory excellence, working closely with health authorities, contract manufacturers, and internal stakeholders to uphold strict industry standards.
Your New Role:
As a Quality Assurance Specialist, you will be responsible for managing quality activities to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicinal products. Your key duties will include:
- Overseeing the product release and compliance process, verifying documentation completeness, and ensuring adherence to quality standards.
- Maintaining and enhancing Quality Systems, including Change Control, Deviations, Complaints, Product Quality Reviews (PQRs, Recalls, and Returns.
- Acting as a liaison with Health Authorities, ensuring timely reporting of quality incidents and overseeing compliance with company policies.
- Managing risk assessment and documentation, supporting technical knowledge-sharing within the organisation
- Implementing and monitoring Corrective and Preventative Actions (CAPAs), tracking effectiveness, and preparing reports for senior leadership.
- Engaging in continuous improvement initiatives to drive operational excellence.
What You’ll Need to Succeed:
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Biochemistry, or a related field.
- Minimum of 5 years of experience in Quality Assurance, Quality Control, or a related function within the pharmaceutical or healthcare industry.
- Certifications in GMP and GDP
- Strong understanding of regulatory affairs, quality assurance, and pharmaceutical guidelines.
- Proven experience managing quality systems, pharmaceutical product releases, and compliance-related activities such as Change Control, CAPAs, and Deviations.
- Demonstrated ability to lead or participate in quality improvement projects.
- Previous exposure to regulatory audits and interactions with Health Authorities is highly desirable.
Quality Assurance Specialist employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Make sure to familiarize yourself with the latest GMP and GDP regulations. Understanding these guidelines 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 who work in quality assurance. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed quality systems or led improvement projects in your previous roles. Concrete examples will showcase your experience and problem-solving skills.
✨Tip Number 4
Stay updated on current trends and challenges in the pharmaceutical industry. Being knowledgeable about recent developments can set you apart during discussions with potential employers.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Understand the Company: Familiarize yourself with the global pharmaceutical organization and its commitment to quality and compliance. Highlight your understanding of their mission and values in your application.
Tailor Your CV: Make sure your CV reflects your relevant experience in Quality Assurance, especially your knowledge of GMP and GDP. Include specific examples of your past roles and achievements that align with the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your qualifications and passion for quality assurance in the pharmaceutical industry. Mention your experience with regulatory audits and your ability to manage quality systems effectively.
Highlight Continuous Improvement Initiatives: In your application, emphasize any previous involvement in continuous improvement projects. Discuss how you have contributed to operational excellence and the implementation of Corrective and Preventative Actions (CAPAs).
How to prepare for a job interview at Hays
✨Know Your GMP and GDP
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Be prepared to discuss how you've applied these principles in your previous roles, as this will demonstrate your expertise and commitment to quality assurance.
✨Showcase Your Experience
Highlight your relevant experience in Quality Assurance, especially any specific projects or initiatives you've led. Use concrete examples to illustrate your ability to manage quality systems and ensure compliance with industry standards.
✨Prepare for Regulatory Questions
Since the role involves liaising with Health Authorities, be ready to answer questions about your experience with regulatory audits and compliance. Familiarize yourself with common regulatory challenges in the pharmaceutical industry and how you've successfully navigated them.
✨Emphasize Continuous Improvement
Discuss your involvement in continuous improvement initiatives. Share specific examples of how you've contributed to operational excellence and the impact of your efforts on quality outcomes within your organization.
