About the role
Quality Engineer (Validation) at Abbott's Manufacturing Site in Tuas, Singapore. Ensure timely execution of change control and validation activities. Develop, execute, and review validation protocols and documentation. Lead FMEA for new equipment. Manage site Validation Review Board (VRB) and approve change controls. P
HealthcareOnsite
Key Responsibilities
- Develop, execute and review validation protocols and related documentation.
- Lead Failure Mode Effects Analysis (FMEA) for new equipment.
- Manage site Validation Review processes (VRB) and approve change controls.
- Perform root cause analysis and identify corrective and preventive actions.
- Support resolution of validation events and escalate concerns.
- Coordinate and support periodic plant stoppage activities related to validation and change control.
Requirements
- Degree in a Science or Engineering discipline.
- Diploma in a Science or Engineering discipline with minimum 3 years working experience.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Familiarity in developing SOPs and work flows.
- Knowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys).
- Proficient in Microsoft applications (Powerpoint, Word, Excel).