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- Tasks: Ensure quality and compliance in drug product development and release.
- Company: Join a leading biotechnology company making waves in drug innovation.
- Benefits: Competitive salary, dynamic work environment, and opportunities for growth.
- Why this job: Make a real impact on healthcare while working with cutting-edge technology.
- Qualifications: Degree in a scientific field and experience in Quality Systems required.
- Other info: Site-based role in Oxfordshire with a focus on regulatory compliance.
The predicted salary is between 34000 - 46000 £ per year.
We are currently looking for a Quality Assurance Officer to join a leading biotechnology company based in the Oxford area. As the Quality Assurance Officer, you will be responsible for ensuring the highest standards of quality and regulatory compliance within a dynamic and innovative environment. This role offers the chance to make a significant impact on the development and release of cutting-edge drug products for both clinical and commercial use.
KEY DUTIES AND RESPONSIBILITIES:
- Manage the batch review program to ensure timely release of drug products, including Qualified Person release for the EU.
- Maintain and manage the internal and external audit program, leading audits of GMP materials and service providers.
- Oversee QA review of change controls and deviations related to Operations.
- Assist in establishing, implementing, and maintaining Quality Management Systems (QMS) in compliance with FDA, MHRA, and other regulatory standards.
ROLE REQUIREMENTS:
- Relevant degree in a scientific or technical field.
- Extensive industry experience in Quality Systems within a regulated biotechnology or pharmaceutical environment.
- A working knowledge and practical experience with GXP, including auditing.
Your next opportunity is just a click away!
QA Officer employer: Hyper Recruitment Solutions LTD
Contact Detail:
Hyper Recruitment Solutions LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Officer
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines from the FDA and MHRA. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to quality assurance in the biotechnology sector.
✨Tip Number 2
Network with professionals in the biotechnology and pharmaceutical industries. Attend relevant conferences or webinars, and connect with QA Officers on platforms like LinkedIn. This can provide you with 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 conducted audits in your previous roles. Highlighting your hands-on experience with GXP and regulatory compliance will set you apart from other candidates.
✨Tip Number 4
Research the company’s recent projects and developments in drug products. Showing that you understand their work and how you can contribute to their goals will make a strong impression during your interview.
We think you need these skills to ace QA Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly within biotechnology or pharmaceutical environments. Emphasise your knowledge of GXP and any auditing experience you have.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key duties mentioned in the job description. Explain how your background aligns with their requirements, particularly your experience with Quality Management Systems and regulatory compliance.
Highlight Relevant Qualifications: In your application, clearly state your relevant degree and any additional certifications related to quality assurance or regulatory compliance. This will help demonstrate your suitability for the role.
Use Industry Keywords: Incorporate keywords from the job description, such as 'GMP', 'FDA Compliance', and 'Batch Review', throughout your application. This can help your application stand out and show that you understand the industry.
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your Regulations
Familiarise yourself with the key regulations such as FDA and MHRA guidelines. Be prepared to discuss how you have applied these in your previous roles, especially in relation to Quality Management Systems.
✨Demonstrate Your Experience
Highlight your extensive industry experience in Quality Systems. Prepare specific examples of how you've managed batch reviews or conducted audits, as this will show your practical knowledge and problem-solving skills.
✨Showcase Your Attention to Detail
As a QA Officer, attention to detail is crucial. Be ready to provide examples of how your meticulous nature has positively impacted quality assurance processes in your past roles.
✨Prepare Questions
Have insightful questions ready about the company's quality assurance practices and future projects. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
