Quality Systems Manager – Switzerland

Full Time
Switzerland
Posted 10 months ago

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.

Location: Switzerland

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.

 

Required competencies

  • 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.

 

To apply please email info@acr-uk.com or give us ring on +44 (0) 114 270 1741.