Job Responsibilities:
1. Responsible for Maintaining Plant Procedure for FUE and Software Validation, that complies with QMS structure.
- Write the Validation Assessment (FUE Qualification) and Software Validation Assessment (Software Validation), IQ, OQ and PQ Protocol and follow through the protocol execution.
- Prepare the IQ, OQ, PQ, VCR Report and all associated Validation documents, review with the Process Owner and route for approval.
- Maintain the Master Validation Plan (MVP) and Master Validation Report (MVR).
- Lead / participate in Kaizen Projects (Continuous Improvement Projects)
- Organize and perform internal audit of the Plant MVP and MVR.
- Prepare Management Review report.
- Support all external audits.
- Review the existing MVR and Software List to ensure compliance to the validation procedures.
- Conduct training on FUE and Software Validation related procedures to Peers.
2. Responsible for Maintaining Plant Procedure for Equipment Calibration, that complies with QMS structure.
- Maintain the Calibration Master List.
- Prepare and Issue Calibration Recall List and manage the Recall Process.
- Review and doc in the Equipment Calibration Records and Calibration Certificate.
- Coordinating with approved suppliers or internal facilities group to perform calibration.
- Lead / participate in Kaizen Projects (Continuous Improvement Projects)
- Organize and perform internal audit of the Plant Calibration Master List.
- Prepare Management Review report.
- Support all external audits.
- Conduct training on Calibration related procedures to Peers.
Job Requirements:
- Minimum Diploma in Engineering
- Project Management and Leadership abilities
- Team Leader and Quality Advocate
- Technical Writing Skills
- Analytical and Logical thinking in relation to Calibration and Validation activities
