We have received instruction from my client, a leading global European Pharma, to find an experienced Quality Systems Manager to establish and maintain their Quality Documentation Management System on a full time basis.
Reporting Line: Head of Quality Systems
Core mission of the clients quality department:
- Protect customers from product quality defects (from Innovation to Solution);
- Design and coordinate the implementation of the company GxP Electronic Quality Management System, and promoting its continuous improvement;
- Evaluate the robustness of the EQMS and weigh in on quality risks;
- Ensure customers satisfaction as well as regulatory compliance in all markets.
Core mission of the role:
- Design and maintain a wide Electronic Quality Document Management System that consolidates regulations into the clients requirements for drug, food, medical device and cosmetic products in a harmonised approach through policies, computerised systems, quality indicators.
- Design and deliver training on the EDMS
- Coordinate the creation of policies and Corporate SOPs in line with international standards applicable to drugs, food, cosmetics and medical devices.
- Implement and maintain Computerised System for Quality Management and Documentation Management.
Key responsibilities of the role:
- Establish the corporate Electronic Quality Documentation Management System (eQDMS) and ensure its continuous updating;
- Ensure the maintenance and the deployment of the training matrices of the corporate Quality Documents;
- Define improvements to the computerised systems required for eQDS activities and ensure their deployment;
- Develop and analyse eQDMS indicators;
- Ensure that the strategy for the management of archives and records is defined and implemented;
- Ensure the implementation and monitoring of quality management processes;
- Facilitate working groups according to identified needs relative to eQDMS and follow up planned actions.
- Draft or contribute to the writing of policies and corporate SOP’s: procedures, instructions, forms;
- Contribute to the interpretation of regulatory requirements in order to anticipate changes in the corporate Quality Documents.
- Experience of owning an eQDMS
- 10 years experience of pharma, medical device, consumer or related industries; experience in Quality Assurance, process improvement, or related function.
- Excellent verbal and written communication skills
- The ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
- Strong analytical, project management skills.
- English fluent written and oral
- MS Office (Excel, Power Point).
- eDocument Management, Training, CAPA’s, Audit systems and tools.