We are currently looking for a Quality Assurance Officer to join a leading biotechnology company based in the Milton Park 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:
Your duties as the Quality Assurance Officer will be varied however the key duties and responsibilities are as follows:

1. Manage the batch review program to ensure timely release of drug products, including Qualified Person release for the EU.
   
2. Maintain and manage the internal and external audit program, leading audits of GMP materials and service providers.
   
3. Oversee QA review of change controls and deviations related to Operations.
   
4. Assist in establishing, implementing, and maintaining Quality Management Systems (QMS) in compliance with FDA, MHRA, and other regulatory standards.
   
   ROLE REQUIREMENTS:
   To be successful in your application to this exciting role as the Quality Assurance Officer, we are looking to identify the following on your profile and past history:
   
5. Relevant degree in a scientific or technical field.
   
6. Extensive industry experience in Quality Systems within a regulated biotechnology or pharmaceutical environment.
   
7. A working knowledge and practical experience with GXP, including auditing.
   
   Key Words:
   Quality Assurance / QA Officer / Biotechnology / Pharmaceutical / GMP / FDA Compliance / MHRA Guidelines / Batch Review / Quality Management Systems / Regulatory Compliance /
   
   Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career