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- Tasks: Manage quality activities to ensure compliance with industry standards for medicinal products.
- Company: Join a global pharmaceutical leader focused on 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 a relevant field and 5 years of QA experience required.
- Other info: Ideal for those passionate about quality assurance in the healthcare sector.
The predicted salary is between 36000 - 60000 £ per year.
Your new company is 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 involves 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 will 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.
If you are interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
QA Specialist employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Specialist
✨Tip Number 1
Familiarise 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 in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical sector, especially those involved in quality assurance. Attend industry conferences or webinars to make connections that could lead to referrals or insider information about the role.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed quality systems or led improvement projects in your previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research the company’s recent quality initiatives and regulatory interactions. Showing that you are informed about their operations and challenges can give you an edge during the interview process.
We think you need these skills to ace QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance and compliance within the pharmaceutical industry. Emphasise your familiarity with GMP and GDP, as well as any certifications you hold.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities of the QA Specialist role. Mention your experience with quality systems, product releases, and your ability to manage compliance-related activities.
Highlight Relevant Experience: In your application, focus on your past roles that involved managing quality activities, risk assessments, and interactions with Health Authorities. Use specific examples to demonstrate your expertise and achievements.
Showcase Continuous Improvement Initiatives: Discuss any continuous improvement projects you've led or participated in. Highlight how these initiatives have driven operational excellence and contributed to quality assurance in your previous roles.
How to prepare for a job interview at Hays
✨Know Your GMP and GDP Inside Out
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Be prepared to discuss how these regulations impact quality assurance processes and share examples from your past experience where you've successfully implemented these standards.
✨Showcase Your Experience with Quality Systems
Highlight your experience managing quality systems, particularly in areas like Change Control, CAPAs, and Deviations. Prepare specific examples that demonstrate your ability to maintain compliance and improve quality processes, as this will be crucial for the role.
✨Prepare for Regulatory Questions
Since the role involves liaising with Health Authorities, expect questions about regulatory audits and compliance. Brush up on your knowledge of regulatory affairs and be ready to discuss any previous interactions you've had with health authorities or experiences during audits.
✨Emphasise Continuous Improvement Initiatives
The company values continuous improvement, so be ready to talk about any initiatives you've led or participated in. Discuss how you identified areas for improvement, the actions you took, and the outcomes achieved to demonstrate your commitment to operational excellence.
