Quality Systems Analyst II — MasterControl Specialist

Boston Scientific

Cork

On-site

EUR 70,000 - 90,000

Full time

5 days ago

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Job summary

Boston Scientific is seeking a Quality Systems Analyst to configure and maintain MasterControl for a pharmaceutical product undergoing transfer to Cork. You will ensure system changes are qualified, documented, and aligned with the global Pharmaceutical Quality System framework, including CAPA and validation activities.

The role requires strong GMP/ISO/ICH/CFR knowledge, data analysis using Excel/Power BI, and experience with electronic document management systems.

Qualifications

NFQ Level 8 honours degree in STEM or related field.
Knowledge of GMP, ISO, ICH, CFR in the medical device and/or pharmaceutical industry.
Knowledge of Computer Systems Validation.
Ability to analyse data using Excel/Power BI or equivalent.
Experience maintaining an electronic document/training management system; MasterControl preferred.
Excellent verbal, written and interpersonal skills.

Responsibilities

Configure and maintain MasterControl for the pharmaceutical product transfer to Cork.
Manage patch and upgrade qualification, defect resolution, and validation summary reports.
Ensure changes are governed by GMP/validation processes and CAPA activities.
Draft work instructions and support performance qualifications and testing.
Collaborate with site and global teams to implement changes and ensure training compliance.