• 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.
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
A company operating in Batam, Indonesia, likely involved in manufacturing or related operations.