QA Manager GxP Systems
QLS are recruiting for a QA Manager GxP Systems to join an important project with a global Pharmaceutical Company at their site based in Alschwil on a contract basis for 12 months.
The main purpose of the role will be: The QA manager, GxP systemsis responsible for the implementation and daily maintenance of QA GxP Quality Systems and processes at Company, in accordance with GxP expectations and for carrying out the quality control check of draft QS Documents and related DCCs (Document Change Controls) prepared using the Veeva Vault Quality workflows:
- Tasks for QA owned GxP system and process oversight:
- Perform monthly introduction on QA systems and processes to new employees (HQ)
- Organize, and drive training and onboarding activities of the Veeva experts
- Contribute to the GxP document/QA process management system adoption within Idorsia worldwide, and monitor they are properly followed in the affiliates and departments
- Obtain user feedback and contribute to optimizing the service
- Analyse the problems of end-users and finding appropriate solutions in collaboration with GIS / technical
- Prepare regular statistics on Quality Management System activities user support and feedback, in alignment with QA systems Business Owner(s) and Management
- Support the business owner and the system owner for the business/technical aspects of the validation and operations of QA owned GxP systems, as needed
- Support the GxP systems team during regulatory inspections or internal audits with regard to applicable QA and Quality Management computerised system(s) content and processes
- Tasks for QA owned GxP systems content management (QA S&P role in Veeva Vault Quality):
- Perform the QA S&P reviews for QS Documents and DCC workflows, checking the accuracy and compliance of the workflows and related contents with current procedures
- Assess, for any Qs Document modification, the impact on the associated training requirement, in collaboration with the author and the Veeva Expert, and in alignment with the training matrix
- Manage the incoming QA Systems related tickets from Assist, in collaboration with GIS, and ensure accurate and timely follow up and resolution
- Implement the agreed modification or creation, in alignment with the central training matrix
- Create training assignments for managing as needed educational training for users
- Create, assign and monitor quizzes in Veeva Vault Quality, based on the user's needs and compliance requirement
- Escalate recurring issues encountered by users and enhancement needs on the system & the processes
- maintain an excellent understanding of the GxP document/QA process management system processes and usage, especially VeevaVault Quality, allowing to be Idorsia trainer for the use of QA GxP systems and processes
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Minimum of 5 years working ina GxP regulated environment
- Experience in QA owned GxP systems including process, content and CSV management
- Experience in international cross-cultural relations
- Well organized, ability to work independently and to plan and prioritize owntasks and align with those of other QA Manager(s) GxP Systems
- Well-developed computer knowledge, especially in Quatro & other Office Package Software
- Ability to put oneself in the position of a GxP system user, and, based on this, to shape training, answer users' inquiries accordingly and emphasize the benefits of GxP systems
- Experienced in and capable of dealing with people of different cultures, educational backgrounds, and computer knowledge
- Experienced in giving presentations and standing in front of an audience
- Reliable, conscientious and detail oriented
- Maturity to work across all levels and functions, used to customer-oriented service
- Excellent team player and the ability to perform effectively under stress, ability to independently deal with complex situations
- Trained with advanced profile on documents and training relevant systems (Quatro, Veeva, etc...as needed)
- Excellent written and verbal communication skills, fluent in English. Workingknowledge of German and/or French also preferred
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference 51158 in all correspondence.
