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- Manage deviation investigations and CAPAs of high complexity and related to process or technical events.
- Support Manufacturing Operations in tracking process parameters.
- Support Quality and business-quantity risks.
- Gap Analysis of QMS, Quality alerts and GQMPs/GGs.
- Prepare documents and trainings materials as required to support the activities of the department.
- Identify, manage, and execute improvement initiatives in batch record improvement, process improvement, alarms management, materials management, and operational excellence (OE) initiatives.
- Support manufacturing team in executing validation, trials, development, and technical transfer where necessary.
- Develop relationship within the value stream team to ensure delivery of production objectives.
- Plan, manage and execute deliverables through proper and timely request and utilization of resources to ensure delivery of projects.
- Coach and provide guidance to the Operations Engineer in their daily task.
- Assist Senior Operations Executive / Manufacturing Managers in ensuring the quality and delivery of task/projects assigned to the team of Operations Engineers.
- Involve in proposals and recommendations of process improvements
- Minimum bachelor’s degree in engineering or science discipline
- Minimum 1 year of pharmaceutical experience ;Candidates without any prior working experience but with good relevant degree are highly encouraged to apply for junior role.
- Good Troubleshooting skills.
- Effective communication, organization, and project management skills.
- Team player
- Plus knowledge of autoclave, CIP, SIP processes