Objective: Develop project plans, manage budgets, monitor progress, identify & mitigate risks, ensure adherence to technical standards and safety regulations in an organization's goal.
Key Accountabilities: To take core responsibilities in achieving departmental KPIs/Goal settings in aligning with organizational technical objectives.
Ensure the overall projects milestone are on track in OEM's events by achieving customer's satisfaction in planning, sample trials preparation, quality appearance/accuracy and delivery.
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Objective: Develop project plans, manage budgets, monitor progress, identify & mitigate risks, ensure adherence to technical standards and safety regulations in an organization's goal.
Key Accountabilities: To take core responsibilities in achieving departmental KPIs/Goal settings in aligning with organizational technical objectives.
Ensure the overall projects milestone are on track in OEM's events by achieving customer's satisfaction in planning, sample trials preparation, quality appearance/accuracy and delivery.
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Objective: To lead Product Life Cycle Management (PLM), LN, accuracy of BOM, ECR/ECN implementation and monitoring. To ensure department KPI is achieved.
Key Accountabilities:
To take core responsibilities in achieving departmental KPIs/Goal settings in aligning with organizational technical objectives.
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Prepare, review, and manage URS for sterile manufacturing systems including but not limited to; Aseptic filling lines, Isolators, Autoclaves and sterilization equipment, Depyrogenation tunnels, Cleanroom and HVAC systems, Critical utilities (Purified Water, Water for Injection, Clean Steam, Compressed Air), Environmental Monitoring systems, Laboratory and support equipment
Ensure URS complies with GMP, aseptic processing and regulatory expectations.
Coordinate with Engineering, Production, QA, QC, and vendors during URS finalization.
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