Quality Engineer
PharmaQuality Assurance
Job description
• 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. Find Jobs for Employees Find Jobs for Contingent Worker
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