Job Reference: J5632292
Updated On: 01/10/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior QA Officer to join a leading Cell & Gene Therapy company based in the South East. As the Senior QA Officer, you will be responsible for managing the QMS and training the QA team on the quality systems.
Key Duties and ResponsibilitiesYour duties as the Senior QA Officer will be varied. However, the key duties and responsibilities are as follows:
1. You will be responsible for the QA team in regards to the batch documentation review, ensuring GMP compliance is maintained and that products released meet GMP requirements.
2. As the Senior QA Officer, you will managing all aspects of the Pharmaceutical Quality Systems (PQS), including OOS and Deviation investigations, Root Cause Analysis (RCA), CAPA and Change Control management, and Quality Risk Management.
3. You will be responsible for performing internal audits, customer and regulatory audits, and facility walk rounds, ensuring inspection readiness beforehand and following up with audit reporting.
4. As the Senior QA Officer, you will be manage and review the QMS, provide training on the QMS and support the continuous improvement of the QMS at all times.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior QA Officer, we are looking to identify the following on your profile and history:
1. Relevant Life Sciences degree.
2. Proven industry experience of managing a QMS within GxP environments.
3. A working knowledge and practical experience with GMP and GCP requirements.
Key Words: Cell Therapy / Gene Therapy / QMS / Quality Management System / Batch Review / Batch Release / PQS / Pharmaceutical Quality Systems / OOS / Deviations / RCA / CAPA / Change Controls / Quality Risk Management / Audit / Internal Audit / Customer Audit / Regulatory Inspection / Facility Walk Rounds / Continuous Improvement / Training Staff / cGMP / GMP / GCP / GxP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.
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