Quality-Automation Liaison
Responsibilities:
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Initiate Document Tracking once finished draft received from Automation Engineer.
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Organize and trace document lifecycle, on AttachePro.
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Liaise with Quality Assurance, Quality Compliance, Computerised System Validation for Automation Documents.
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Learn manufacturing process and respond to test event deviations, keep track of repetitive responses for re- use and create where required.
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Support automation projects (Delta V, PLC/SCADA and OSI PI) in accordance with policies and procedures.
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Obtain approval for system installation, configuration, testing and commissioning documents.
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Manage Computer System Validation Lifecycle from design to execution phases.
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Once more experience is gained, ability to evaluate change requests and assist in drafting.
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Any other task as assigned by Supervisor/Manager.
About You:
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Industrial, Pharmaceutical, Chemical or relevant Engineering degree.
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Basic knowledge of Automation System Architecture is required, exposure to Emerson DeltaV is a plus but not required, training will be provided.
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Knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP)
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Adaptable, proactive, able to build relationship with other professionals.
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Must be team player, curious with strong analytical and organizational skills.