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Quality System Analyst at Boston Scientific Cork

cork, Dublin County, Ireland -

Full Time

Start Date

Immediate

Expiry Date

18 Dec, 26

Salary

80000.0

Posted On

19 Sep, 26

Experience

12 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Contribute to detailed analysis (provision of metrics for system monitoring, identification of improvements) and documentation of processes with emphasis on information flow (all communications must be clear and accurate).
Work with team members to identify and translate process analysis/ improvements identified into a detailed configuration or into changes in ways of working to improve efficiency and reduce overheads.
Primary responsibility is to maintain rigorous control of configuration changes via the system according to computer systems validation regulations and processes (e.g., GAMP 5). This includes analysis of potential impacts of quarterly system updates, confirmation of defect resolution and qualification of system enhancements for use. Where issues are identified, will take part in documentation of issues, investigations and CAPA activities.
Work closely with all site and global resourc

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Responsibilities

Contribute to detailed analysis (provision of metrics for system monitoring, identification of improvements) and documentation of processes with emphasis on information flow (all communications must be clear and accurate).
Work with team members to identify and translate process analysis/ improvements identified into a detailed configuration or into changes in ways of working to improve efficiency and reduce overheads.
Primary responsibility is to maintain rigorous control of configuration changes via the system according to computer systems validation regulations and processes (e.g., GAMP 5). This includes analysis of potential impacts of quarterly system updates, confirmation of defect resolution and qualification of system enhancements for use. Where issues are identified, will take part in documentation of issues, investigations and CAPA activities.
Work closely with all site and global resourc