Senior Executive

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.

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.

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