Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.
Work with QA and stakeholders to develop the CSV strategy
Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols.
Responsible for test case execution, deviation handling and drafting of system SOPs.
Any other task as assigned by Supervisor/Manager.
About You:
Bachelor Degree in a scientific or related engineering discipline with at least 5 years' experiences in CSV QA validation.
Good understanding of DeltaV coding and configuration in order to support CSV protocol generation and review for DeltaV processes.
Knowledge of validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Familiar with Health Authorities standards (e.g. FDA CFR and EU)
Must be team player, curious with strong analytical and organizational skills
Duration
: 09 months.
Based in Tuas.
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