Provider shall perform and complete the services as defined below and as further defined in the iQMS Project Plan:
- Generate validation documentation related to the iQMS electronic solution (MasterControl).
- Create and review documentation as required but not limited to PQ Protocols, validation plan, Validation Summary report and third party documentation.
- Update the Traceability matrix during project validation lifecycle.
- Create and validate any Migration tools required to export existing data to new electronic solution iQMS.
- Perform Data migration activities in accordance with the Data Migration Strategy
- Ensure legacy data for current QMS electronic solutions are archived and accessible in human readable format.
- Contribution and review of additional validation documentation for example work instruction, deployment plans, data migration protocols and associated reports.
- Generate decommissioning documentation for existing QMS electronic solutions once MasterControl is fully deployed within the company.
- Maintain a strong technical understanding of Quality System regulations, Validation and Data Integrity.
- Good Knowledge and understanding of Pharmaceutical and medical device regulation and Guidelines (QSIT, ISO 13485:2016, ICH Q9, ICH Q10 EudraLex Volume 4 Part 1, GAMP 5)
- Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
- Carry out other reasonable tasks as required by line manager.
- It is understood by Provider that this service will be delivered on site.
If you are interested in exploring further and have the required experience, please send your CV to email@example.com