Perform testing and/or inspection on raw material, in-process material, finished products and monitoring activities.
Review/Approve testing documentation and test records.
Maintain integrity, accuracy and completeness of QC data and records.
Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
Timely completion of all compliance activities without overdue, including but not limited to NCI, OOS, CAPA, Effectiveness Check, CR, training, periodic review.
Timely report non-conformance or out-of-specification events. Lead or assist in root cause analyses for product defects and quality lapses, and take effective actions to prevent recurrence.
Drive and promote the continuous improvement culture. Challenge current processes, identify improvements and drive the effort to implement lab system/process while maintaining compliance and reducing human Intervention.
Review and assess external standard and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance
Perform basic equipment troubleshooting.
Investigate underlying causes, technical faults and issues pertaining to laboratory equipment, method or practices, and take necessary actions to resolve the problems.
Develop testing protocols and procedures for Quality Control activities
Develop APQR sub-reports and ensure timely submission of sub-reports without overdue.
Participate in new product transfer or second sourcing projects and ensure laboratory readiness according to timeline to support the site objectives.
Determine and implement optimal approach for laboratory equipment calibration, maintenance and operation. Ensure laboratory infrastructure and equipment function as intended.
Site point of contact for global communities/initiatives
Compile data to support business and performance metrics reporting
Provide guidance, coaching and training to the team as required.
Participate directly in laboratory inspections, internal and external audits
Develop sampling plans for Quality Control purposes and cascade guidelines for optimal sampling conditions to laboratory personnel
Analyse data to identify unfavorable trends and address issues with relevant stakeholders and to drive improvement on the method robustness
Assist in PQR and OPV with cross functions (MS&T, Compliance) and perform related investigation if required.
Review, report and analyse data to support business and performance metrics reporting
Monitor the effectiveness of improvements and changes made to QC activities, methods and workflows
Perform any other duties as assigned by Supervisor according to business needs.
Certified trainer to conduct on-the-job training
Perform routine calibration and maintenance of laboratory equipment
Planning/Assigning of tests and activities
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