Job Description

Requirements:

• At least 3-5 years experience in pharmaceutical/medical device industry with GMP knowledge.
• Strong understanding and hands-on experience of setting up and maintaining Laboratory Information Management System (LIMS).
• Experience of working in/with QC laboratory. Understand QC requirements and laboratory processes/workflow.
• Experience of leading projects in medium to large scale is an added advantage.
• Experienced in data analysis or data analytic is an added advantage.
• Greenbelt certified (preferred)

Job Summary:

• Lead, manage and execute LIMS-related activities and projects. Maintain LIMS master data to support QC operations. Drive and promote a continuous improvement culture to improve the quality and efficiency of QC workflow and processes.

Job responsibilities:

• LIMS SME:

• Subject matter expert (SME) for LIMS. Maintain LIMS master data. Perform master data change, including impact assessment, change control, validation/verification and re-validation activities.
• Maintain and improve LIMS to support QC operations (including Incoming Quality Check, Chemistry Laboratory and Microbiological Laboratory).
• Support data interfacing between laboratory testing assets and LIMS.
• Lead and/or execute projects pertaining to LIMS enhancement or initiatives.
• Site point-of-contact for global LIMS community or other communities/initiatives.
• Primary point of contact for day-to-day operational issues pertaining to LIMS. Lead the investigation or troubleshooting, identify underlying causes and implement necessary corrective & preventive actions.
• Collaborate with relevant stakeholders (e.g., QC Operations, QA Operations, MS&T, Production, IT) to understand business needs and drive improvement on the system or process.
• Develop protocols and operational procedures for systems/processes.
• Streamline and improve data trending and reporting processes.
• Change agent for the digital transformation journey and able to influence peers to embark the new ways of working.
• General responsibilities:

• Meet quality objectives set by management & comply to Alcon, Quality Management System (QMS) and Safety requirements.
• Perform root cause analyses for non-conformance events as a certified investigator, and identify effective actions to prevent recurrence.
• Timely completion of all compliance activities without overdue, including but not limited to Non-conformance Investigation, OOS, CAPA, Effectiveness Check, Change Request, training, periodic review.
• Provide guidance, coaching and training to the team as required.
• Participate in supporting laboratory inspections, internal and external audits.
• Review, report and analyse data to support business and performance metrics reporting.
• Review and assess external standard and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance.
• Review/approve records/documents. Maintain integrity, accuracy and completeness of data and records.
• Improve quality and efficiency of QC workflows/processes:

• 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.
• Lead and execute continuous improvement projects by applying lean six sigma tools.

Expectation:

• Independent and able to manage time and plan for activities to meet set timeline.
• Communicate effectively with people from different departments/levels in the organization.
• Strong technical writing skills. Able to develop protocols, procedures, reports independently.
• Strong problem-solving skills. Able to resolve a wide range of issues in innovative ways without compromising quality.
• Fast learner and willing to learn and expand skills and knowledge.
• Able to work in a collaborative, team-oriented environment.

ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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