Validation Engineer
We are looking for a Validation Engineer who can speak Mandarin language.
Pharma Domain experience is a must.
· Manage the entire GxP change control process from initiation to closure to meet the requirements from project stakeholders. This includes global GxP systems that is used across Americas, APAC, China, EU, etc.
· · Collaborate with project stakeholders to author validation deliverables (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc.) and revise accordingly based on guidance and feedback from Quality team.
· Manage validation activities of cross functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
· Support resolution and documentation of protocol and test discrepancies.
· Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
· Help maintain post go live activities such as managing user onboarding documentation, revision release notes assessment for validation impact, assist with quarterly system access review documentation, etc.
Maintain computerized system validation documentation
