Senior Quality Assurance Associate

Our client is a cutting-edge biotechnology company dedicated to revolutionising the healthcare industry through the development and production of next-generation biopharmaceuticals. Their state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. Due to expansion and growth they are seeking a Senior Quality Assurance Associate to join our Quality Assurance team and ensure the highest standards of product quality and compliance.

Responsibilities:

The Senior Quality Assurance Associate will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within the next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold Quality Assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

Skills:

• Develop and maintain Quality Assurance procedures, policies, and systems
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations
• Collaborate with production and Quality Control (QC) teams to ensure product quality throughout the manufacturing process
• Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality

• Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
• Participate in risk assessments and quality improvement projects.

• Stay current with industry regulations, guidelines, and best practices
• Assist in the preparation and execution of regulatory inspections and audits.
• Ensure that all products meet regulatory requirements, including documentation and reporting
• Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports
• Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation
• Perform batch disposition, including approval of drug substance batch records and associated CoA's
• Provide training to staff on quality-related procedures and best practices
• Stay informed about the latest developments in biotechnology and Quality Assurance

Qualifications:

• Ideally degree level education or equivalent practical knowledge of Quality, or related discipline
• Quality assurance within a biotechnology or pharmaceutical manufacturing environment

There is an excellent salary on offer + bonus and benefits package with potential for Hybrid working based ion business needs

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales