1. Handling of electronic Quality Management System e.g. QAMS, DMS & LIMS for configuration, qualification, training, rollout, etc.
2. URS preparation and review for eQMS.
3. Execution, monitoring and review of Qualification / Validation activities related to eQMS
4. Preparation, review and updation of CQA SOPs.
5. Support all manufacturing sites for executional understanding, master data and implementation of new projects.
6. Reporting of events and abnormalities.
7. Coordinate with eQMS vendor for trouble shooting and maintenance of implemented modules.
8. Ensure training of the team on GAMP5, 21 CFR part 11.
Spectrum Talent Management is a forerunner in designing Human Resources solutions specific... to the local needs of our respected clients. Providing services to clients globally our unique implementation methodology has been developed for speedy ramp-up to cater to the ever urgent needs of the industry as well as ensuring that we apply systems, measures and best practice processes in order to meet the demanding SLAs set by our clients. Read full description