Senior Quality Assurance Associate

R Dpartners; Greater London; On-site; GBP 60,000 - 90,000; Full time

Job summary

R&D Partners in London is seeking a Senior Quality Assurance Associate to oversee QA across manufacturing and operations, ensuring GMP compliance and driving continuous improvement throughout the site.

The role emphasizes leading QMS enhancements, reviewing GMP documentation, and supporting product release activities in a cutting-edge biotechnology environment.

Qualifications

• Minimum 5 years of experience in a sterile GMP manufacturing environment.
• Strong background in QA and compliance.
• Hands-on experience with regulatory inspections and audits.
• Excellent knowledge of Quality Systems and GMP requirements.

Responsibilities

• Provide QA oversight across manufacturing and operational functions.
• Manage and continuously improve the Quality Management System (QMS).
• Review and approve GMP documentation, including SOPs, quality processes, and training materials.
• Support batch record review and GMP product release activities.
• Lead quality investigations, including deviations, CAPAs, change controls, risk assessments, and OOS activities.
• Perform internal audits and support customer and regulatory inspections.
• Deliver compliance training and mentor QA team members.
• Drive continuous improvement initiatives and promote a quality culture across the site.

Skills

GMP compliance

QA oversight

Quality systems

Regulatory inspections

Job description

Are you a QA professional with a passion for GMP compliance and continuous improvement in a cutting-edge biotechnology environment?

R&D Partners is seeking a Senior Quality Assurance Associate to join a leading biotechnology company in London. This role focuses on providing QA oversight across manufacturing and operational functions, ensuring compliance with GMP standards, and driving continuous improvement initiatives.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Provide QA oversight across manufacturing and operational functions.
• Manage and continuously improve the Quality Management System (QMS).
• Review and approve GMP documentation, including SOPs, quality processes, and training materials.
• Support batch record review and GMP product release activities.
• Lead quality investigations, including deviations, CAPAs, change controls, risk assessments, and OOS activities.
• Perform internal audits and support customer and regulatory inspections.
• Deliver compliance training and mentor QA team members.
• Drive continuous improvement initiatives and promote a quality culture across the site.

Key Skills and Requirements:

• Minimum of 5 years of experience in a sterile GMP manufacturing environment.
• Strong background in QA and compliance.
• Hands-on experience with regulatory inspections and audits.
• Excellent knowledge of Quality Systems and GMP requirements.

For more information, please contact Henry LeLacheur.