Quality Engineer (Validation)
10 months ago
Primary Function:
Ensure that change control and validation activities are executed in a timely manner.
Key Responsibilities:
Develop, execute ..
Primary Function:
- Ensure that change control and validation activities are executed in a timely manner.
Key Responsibilities:
- Develop, execute and review validation protocols and related documentation in accordance with procedures and policies
- Support Failure Mode Effects Analysis (FMEA) for new installations or changes.
- Manage change control documentation in respective data management systems
- 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
- Develop and execute business area improvement projects
- Develop training materials and conduct training
- Participate in internal and external audits
- Participate in division and site projects, improvement activities and technical sharing platforms
- Comply to all policies and standards
- Any other ad-hoc requests as assigned by the supervisor
Requirements:
- Bachelor's Degree in a Science or Engineering discipline
- Min 3 years of related experience in change control and validation in a manufacturing plant required, preferably in Food/Nutrition/Pharma industry
- 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, etc.).
- Familiarity with international and technical standards is a plus (ISO, FSSC etc)
- Proficient in Microsoft applications (Powerpoint, Word, Excel)
- Team player with initiative, drive, good communication skills and a strong command of written English
- Ability to think systematically and with analytical mindset
- Ability to do data analysis using Minitab, JMP is a plus
- Experience in manufacturing process design and equipment design or application is a plus
*Kindly note this position is based in Tuas.
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