We are currently looking for a Quality Project Engineer to join our team.
As a Quality Engineer, you will play a key role in supporting and improving quality standards across the Utilities and Supporting Systems department. You will act as the coordinator for complex quality issues, serving as the link between the department and the quality team. Your proactive approach will help maintain high standards by monitoring key parameters, providing training, and supporting validations and change management.
Main responsibilities:
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Coordinate and resolve complex quality issues within the department.
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Maintain and improve quality standards by monitoring KPIs and QPR.
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Proactively identify potential issues and deliver training as needed.
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Support and guide validation and change management processes.
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Lead and participate in projects to enhance departmental quality standards.
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Collaborate with Engineering and PTS teams to ensure proper implementation of quality standards.
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Serve as the point of contact for change management and quality input for Utility and HVAC engineers.
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Train and educate technicians, engineers, and supervisors on quality-related topics.
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Investigate QARs and improve data integrity through checks and new projects.
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Keep the Validation Master Plan (VMP) up to date and conduct periodic reviews of the validated systems.
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Assist in audit preparations and support the department during audits.
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Support the Quality analyst(s) of the department in performing their duty.
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Organize and update SOPs and instructions in line with c-GMPs and pharmaceutical guidelines.
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Support supervisors and lead engineers in quality and data integrity topics.
