Posted in: Other in Birmingham | Posted: |
We are recruiting on behalf of a client for a Quality Manager (GMP). As they strengthen their Quality and Regulatory team to meet the needs of their growing business.
Our client are a well established supplier of pharmaceuticals to UK and International customers.
Job Ttitle - Quality Manager (GMP)
Industry - Pharmaceuticals
Location - Birmingham
Salary - £40,000 to £55,000 dependent on experience
Hours - Monday to Friday
Brief overview of Duties and Responsibilities:
* Managing the team
* Monitoring and management of the GMP QA department and all QA aspects in respect to GMP activities.
* Effectively monitoring of the operational tasks within the Quality Management System (QMS) and maintain compliance to the current systems including but not limited to:
* Change controls
* CAPA
* Issue management
* Complaints
* Risk Management
* Reviewing and conducting change controls, CAPAs, Deviations, Complaints and Risk Assessments.
* Ensuring quality tools and techniques are used to perform investigations.
* Ensuring thorough investigations are carried out and the root cause is determined. Where a root cause cannot be determined, contributing/possible causal factors must be specified.
* Evaluating and resolving quality issues.
* Proactively driving GMP team towards continuous improvement within QMS activities.
* Ensuring corrective and preventive actions plans implemented address the root cause of non-conformances.
* Manager sign off of deviation/capa reports and all GMP related activity reports.
* Reviewing data from Key QMS outputs and ensure the data is analysed and trends are identified, and appropriate measures are implemented to address trends.
* Ensuring the current QMS is working effectively, seek opportunities for improvement.
* Maintaining and improving existing quality processes to ensure continuously appropriate/compliant operation of quality processes.
* Updating, maintaining, and improving the QMS.
* Writing, updating and approving Quality documents such as SOPs, and work instructions.
* Reviewing qualification of new suppliers of medicinal goods and services.
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