About the role
AI summarisedThe Quality Engineer (Validation) is responsible for ensuring compliance with Abbott's quality policies and standards by developing, executing, and reviewing validation protocols. This role leads FMEA for equipment changes, manages validation review processes, supports quality event investigations, and contributes to audits and continuous improvement initiatives across plant and laboratory environments.
HealthcareOnsite
Key Responsibilities
- Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies
- Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes
- Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests
- Perform root cause analysis and identify corrective and preventive actions in addressing quality events
- Support resolution of validation events and escalate concerns in a timely manner
- Support in equipment and process walkdowns
- Weekly, Monthly and Quarterly reporting as required for own business area
- Support Monthly and Quarterly Quality Management Review (QMR) and Business Management Review (BMR)
- Coordinate and support periodic plant stoppage activities related to validation and change control functions
- Develop and execute business area improvement projects
- Participate in internal and external audits
Requirements
- Degree in a Science or Engineering discipline.
- Diploma in a Science or Engineering discipline with minimum 3 years working experience. Experience/Background
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry.
- Familiarity in developing SOPs and work flows