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CSV Engineer

Job Title: CSV Engineer
Contract Type: Contract
Location: Surrey, England
Industry:
Salary: £50 - £60 per hour
Start Date: 2019-10-13
Reference: BH-117327
Contact Name: Daniel Leach
Contact Email: Daniel.Leach@nesgt.com
Job Published: October 14, 2019 11:26

Job Description

Great opportunity for a CSV Engineer to work a 6 month contract for a Global Healthcare company in Surrey.

Role Responsibilities

Provider shall perform and complete the services as defined below and as further defined in the iQMS Project Plan:
  1. Generate validation documentation related to the iQMS electronic solution (MasterControl).
  2. Create and review documentation as required but not limited to PQ Protocols, validation plan, Validation Summary report and third party documentation.
  3. Update the Traceability matrix during project validation lifecycle.
  4. Create and validate any Migration tools required to export existing data to new electronic solution iQMS.
  5. Perform Data migration activities in accordance with the Data Migration Strategy
  6. Ensure legacy data for current QMS electronic solutions are archived and accessible in human readable format.
  7. Contribution and review of additional validation documentation for example work instruction, deployment plans, data migration protocols and associated reports.
  8. Generate decommissioning documentation for existing QMS electronic solutions once MasterControl is fully deployed within the company.
  9. Maintain a strong technical understanding of Quality System regulations, Validation and Data Integrity.
  10. 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)
  11. 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.
  12. Carry out other reasonable tasks as required by line manager.
  13. It is understood by Provider that this service will be delivered on site.
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

If you are interested in exploring further and have the required experience, please send your CV to daniel.leach@nesgt.com