Quality Assurance Specialist
2 days ago
At SkySys, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will be responsible for the development and execution of validation protocols according to company policies, procedures, user requirements, and industry standards.
Key Responsibilities
• Ensure compliance to respective system management SOPs with respect to user groups and privileges.
• Demonstrate compliance to the established policies, guidelines, and standard operating procedure.
• Ensure IT security policies are implemented, maintained, and followed.
• Support investigations in functional areas.
• Timely communicate/discuss identified gaps to responsible teams. Coordinate with relevant teams for compliance/closure of identified gaps.
• Perform periodic access review of Lead-lab systems with the support of relevant stakeholders.
• Ensure timely completion of assigned trainings (individual as well as team).
• Support drafting SOP/WI for Lab IT support.
• Prepare guidance documents for Lab IT support teams.
• Ensure change controls are in place before implementation of any GxP change.
• Ensure quality and compliance to corresponding standards of following documents:
• All qualification and instrument life cycle-related IT documents.
• For example, but not limited to:
• Qualification documents (IQ 33, IQ 13, OQPQ ERES)
• Installation & configuration documents of Chromeleon
• IPC recovery document
• Backup monitoring report
• IPC Retirement document
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