Senior Good Manufacturing Practice Quality Assurance Associate

A popular biotechnological company are looking for a Senior Good Manufacturing Practice(GMP) Quality Assurance Associate to join their team in Hertfordshire. They are using ground-breaking immuno-oncology approach to rapidly advance therapies. This is a unique opportunity to join a company that can transform the clinical management of cancer.

Job Responsibilities:

• Support the creation, maintenance and continuous improvement of the Quality Management System (QMS)
• QA Review and Approval of Procedures, Master Batch Records, and any Other Relevant cGMP Documentation
• Perform Batch Documentation Review Activities
• Review Standard Operating Procedures (SOPs) to Ensure Compliance with GMP and Other Relevant Regulatory Requirements
• Ensuring for Any Investigations Performed that Product Quality, Safety, Efficacy and Compliance Implications are Accurately Assessed. Identification of Repeat Deviations and Assurance that Appropriate Corrective Actions are Taken.
• Support Complaints Management Process and Where Appropriate Respond to Complaint Investigations
• Support with Any Qualification & Validation Activities
• Perform Internal Audits to Determine Compliance with GMP and Identify Areas for Improvement
• Provide Support and Data for Achilles Quality Management Reviews

Skills and Requirements

• Experience working in QA in a Biotech/Biologics/ATMP GMP Environment -
• Technical Knowledge of Aseptic Manufacturing Processes, Sterility Assurance and Laboratory Techniques
• Thorough Understanding of EU and US GMP Requirements
• Experience within a GMP Quality Assurance Department
• Experience Investigating Deviations, Complaints, Reviewing Change Controls, Implementing CAPAs and Conducting Internal Audits
• Experience with Batch and Associated Documentation and its Review
  

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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