• Support the Serialization team responsible for the implementation of Serialization capability.
• Work closely with the Serialization resources to ensure solutions meets regulatory timelines and deliverable.
• System configuration support.
• Support the Operational Qualification (OQ) and developed associated documentation.
• Data and test scripts in support of IQ, OQ, & PQ validation milestones.
• Develop test scripts, OQ and capturing and preparing documents for review.
• Support and assist in the execution of validation strategy and validation master plans.
• Contribute to project URS, FS, DS and validation documents.
• Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
• Bachelor's in Engineering with 10 years of professional experience.
• Knowledge and experience system configuration support.
• Knowledge and experiences with Optel and SAP.
• Knowledge and experience of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.