Quality System Analyst II

Boston Scientific; Cork; On-site; EUR 70,000 - 90,000; Full time

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.

Skills

QMS

GAMP 5

Excel

Power BI

Data analysis

Documentation

Education

NFQ Level 8 degree in STEM

Tools

MasterControl

Job description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Job Purpose

Analyst responsible for configuring / maintaining an integrated Quality Systems Management System (MasterControl) to support a pharmaceutical product (currently manufactured at Farnham but transfering to Cork). This resource will be a systems expert and will be responsible for sustaining activities including patch and upgrade qualification, and issue resolution. They will be responsible for working with the global Pharmaceutical Quality System management team to understand the business requirements and then configure them within the system

Key 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 resources to define and execute requested changes to existing configurations including updates to configuration specifications, drafting of work instructions, writing and execution of performance qualifications, and completion of validation summary reports.
• Contribute to site and global system testing activities (e.g., global security implementations and standard desk top configuration changes).
• Gain an in-depth working knowledge of the application and touch points with other site and enterprise level systems (e.g., sign-in and security requirements).
• Support for resources during initial launches and rollouts. Assistance/ contribution in transferring records into and out of the system.
• Assist users and come up with initiatives to maintain training compliance for the Pharmaceutical Quality System.
• Provide day to day support to existing implementations (on call working hours support for application including working with supplier system technical support when issues cannot be resolved by local BSC team, new account creation, user role assignment). Author work instructions and use up to date media tools (e.g., video, flash cards) to provide assistance to users.

Education & Experience

• NFQ Level 8 honors degree in STEM or a releated field
• Demonstrated knowledge of Quality Management Systems and relevant standards (GMP, ISO, ICH, CFR etc.) within 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; preferably MasterControl.
• Demonstrated advanced computer skills – Microsoft Office preferred.
• Excellent verbal, written and interpersonal skills.
• Demonstrated success working in a team environment.
• Competent, highly organised individual who pays strict attention to detail.
• Ability to work in partnership with personnel in the Site Functional teams, other sites and customers.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [e-mail]