I am currently searching for a Quality Assurance Systems Manager to join a growing Pharmaceutical company based in Essex. Within this role you will be responsible for implementing and maintaining the company Pharmaceutical Quality System including the Documentation Control System, Deviation, Complaint and CAPA Management.
*To report to Head of Quality and work alongside the Quality Compliance Manager, Senior Business Development Manager, Regulatory Affairs, NPI Manager and MD.
*Ensure that the Pharmaceutical Quality System enables the client to fulfill the requisite responsibilities of an MA Holder
*Preparing, implementing and maintaining the quality systems required to support in addition to Documentation Control System, Deviation, Complaint and CAPA Management, Training and Standard Operating Procedures - Supplier Qualification, Quality Agreements, Technical Agreements and Safety Data Exchange Agreements as Complaints/ADR recording, reconciliation and the internal/external audit program
*To be named and undertake the responsibilities and duties of the Responsible Person as defined within EU Current Good Distribution Practice
*To take responsibility, review and approve the Quality Management System for the client including Quality Manual, Change Control, Deviation Management, CAPA, Quality Risk Management and the Quality System Review
*Manage and develop the Complaint Management System including Recalls and Falsified Medicines
*Manage and develop, review and revision of Standard Operating Procedures with assistance from the Head of Quality
*Assist in the training and implementation of QA procedures for GMP compliance
*Act as primary company contact for Third Party Logistics providers, including the management of the Quality Review process and the preparation, analysis and response to key performance indicators
*Participating in Continuous improvement activities.
*Possible involvement with PV and Medical Information reconciliation, liaising with Business Development Manager and Department, Regulatory Affairs and MD; communicating information and updates as appropriate
*Liaising with the Regulatory department when necessary with regards to review and preparation of SDEAs.
* Quality Assurance
* Compliance Management
* Pharmaceutical Operating Procedures
For further details about this role or other vacancies within Quality Assurance, please contact Tim Barratt on 01727 817 626 or email firstname.lastname@example.org