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Batam, Kepulauan Riau, Indonesia
Onsite
• Assist/Execute/Lead Non-Conformance Investigation, RCA, and the generation/execution of CAPA.
• Review/execute engineering studies/validation/qualification activities for new/existing product/process/raw material/computer systems.
• Perform risk assessment for product/process and system.
• Support/lead Change Request for any product/process improvement.
• Conduct quality oversight at the operation area on a periodic basis.
• Communicate issues related to product quality, disposition of non-conforming products & escalations.
• Support and involved in Compliance Improvement Program.
• Work with manufacturing to implement process improvements.
• Perform assessment, determines GxP applicability (Direct/Indirect impact) of the system.
• Conduct quality oversight for the computerized systems at the operation area on a periodic basis.
• Ensure compliance with lifecycle requirement for Computerized System and its data.
• Review/Execute/Approve validation/qualification activities for new/existing computerized systems.
• Ensure compliance and provide guidance plus technical support to QA/Manufacturing/MST& Engineering.
• Work in-accordance with HSE manual and documented procedures, and reporting HSE issues.
• Leveraging good practices by referencing other Alcon sites.
• Review historical quality performance (non-conformance, customer complaint, escalation) from other Alcon sites.
Qualifications:
• Bachelor's degree in Engineering or a Science-related field.
• 1-2 years of relevant work experience are preferred.
• Experience handling Non-Conformance investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
• Experience supporting validation and qualification activities for products, processes, raw materials, and/or computerized systems.
• Strong communication and stakeholder management skills.
• Good verbal and written communication skills in English.
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