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 (url removed)

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 OC(phone number removed) England and Wales