Description
Our global medical device client has undertaken an investment programme across various systems and requires the support of a CSV in the qualification of new and existing systems.Responsibilities:
- Requalification of ERP (JD Edwards system):
- Review existing validation status of ERP system.
- Carry out GAP analysis and itemise CAPAs.
- Resolve any deviations.
- Complete all related paperwork.
- Support the introduction of a new (cloud based) QMS system:
- QMS system initial to be utilised for document management, CAPAs, and complaint management.
- Create validation plan for the QMS system, execute and deliver all required documentation.
- Work closely with the vendor and client team to ensure a fully operational, compliant system.
- Extensive previous experience working as a CSV Engineer within the Pharmaceutical/Bio-pharmaceutical industry, with a thorough knowledge of GAMP5 requirements.
- Thorough knowledge of the requirements of 21 CFR Part 11.
- Experience with ERP systems (ideally JD Edwards) and QMS systems required.
- Communicate effectively with diverse stakeholders from QA, Manufacturing, QC and Engineering departments to drive project goals and deliverables.
- Personal attributes include self-motivation, excellent communication skills, strong team player and proactive attitude to problem solving.