Job DescriptionMy client, a global health care company in the South East UK has an exciting contract opportunity for an experienced Group QMS Lead.
Reporting to the QMS Integration Manager, you will assure Legacy Electronic QMS platform/system and document updates are implemented in compliance with the Legacy quality system, regulatory requirements and business expectations.
Provide guidance to other sites as required with regards to the QMS and MasterControl. Facilitate changes to Policies, SOPs and WIs and assure consistency with the requirements of the QMS to enable integration.
Principal Responsibilities include
- To be responsible for the effective management and system administration of the Legacy Global Electronic systems including MasterControl.
- Perform re-qualification validation, troubleshooting and training of the Legacy global electronic solutions and MasterControl.
- Lead QMS integration and continuous improvement initiatives and validate any process improvements as required for Legacy Global electronic solutions and MasterControl.
- Generate the metrics/KPI in preparation of the quarterly PI Quality Management Review Meetings
- Manage changes to the Legacy Global QMS documentation
- Ensure compliance in meeting Good Documentation Practice and Good Manufacturing Practice requirements for documentation.
In order to be considered for this opportunity it is essential that you have the following -
- Educated to Degree or equivalent experience.
- Strong technical background in quality system regulations, cGMPs, MHRA, FDA regulations.
- Experience of working within a GMP regulated environment.
- Experience of and direct involvement in implementing electronic documentation and quality management systems.
Skills and Attributes
- Demonstrated in-depth technical knowledge in QMS and associated electronic systems.
- Computer literate, including a good working knowledge of Microsoft Office especially Word, Excel, Visio, Power Point.
- Ability to work proactively and with minimal supervision.
- High attention to detail and accuracy.
- Willingness to travel for up to 10% of time.
To learn more about this exciting opportunity please submit your CV today!