Job Description

This position is responsible for Analytical Testing Lab (ATL) operation to provide Raw Material, Intermediate, Validation and Stability Testing.

Major Accountabilities:
1. Perform testing, review and approve test result and lab records (when necessary).
2. Back-up system owner for laboratory instrument and equipment
3. Issue, conduct NCR and OOS investigation as a certified investigator, identify root cause and determine appropriate CAPA. Ensure all TW record are closed timely.
4. Ensure effectiveness and implement improvements on general laboratory activities that includes sample management and disposal, testing, housekeeping, preparation of reports/emails/memos for intended audience and checking of lab inventory.
5. Implement changes which includes GCM change request, SOP revision, impact assessment and go live plan.
6. Trend, analyse and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary.
7. Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
8. Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
9. Support internal and external audits and is responsible for audit finding closure, as required.
10. Work with cross-functional teams to resolve operational quality issues.
11. Perform duties as assigned by supervisor based on the agreed deliverables and timelines.

12. Serves as a backup for QC Supervisor

Job Qualification:

1. Preferably Bachelor\xe2\x80\x99s degree in Chemistry, Microbiology, or scientific discipline with 3 to 5 years relevant experience. Minimum Diploma with 7 to 10 years relevant working experience
2. 3 to 10 years relevant working experience in medical device or pharmaceutical industry with a good understanding of cGMP, ISO, and FDA requirements.

Alcon