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The Quality Systems Specialist is responsible for ensuring that systems and products manufactured in the Dublin Compounding Facility comply with the Manufacturing Authorization, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.
Job Responsibility:
Ensure the compilation of Quality Management Review process
Review and approval of process change controls, SOPs, NCRs and CAPAs
Implementation, execution and administration of Change Control System and NCR System
Administration of Recall process with the Quality management team
Administration/co-ordination of risk assessments
Support facility projects including process development and quality improvement initiatives
Manage and maintain the Documentation System
Manage of site archive, storage, retrieval and destruction processes
Review and approval of Quality documentation
Supporting all departmental administration systems as required
To assist with the collation of information and assist in the preparation of reports in relation to Annual Product reviews
To ensure that the systems with a GMP impact are maintained as per written procedures
Training of Quality and Manufacturing personnel
Train and provide feedback to document/process owners on errors for continuous improvement
Ensure inspection readiness in work completed
Assist in the internal and external audit program
Participation in regulatory and corporate / internal audits
Conduct audits as per internal audit schedule
Compile and track internal/corporate audit and regulatory inspection responses
Support trending and compilation of investigation/system reports
Preparation of Key Performance Indicators (KPIs)
To administer and develop the complaints system
To monitor the Approved Supplier listing
Manage supplier complaints and investigation processes
Administration of supplier notification/change processes
Support the introduction of new products
Key member of Quality Risk Management and Operational Excellence
Ensure that change controls are compliant with applicable procedures
Support the implementation of the Operational Excellence Programme
Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP)
Compliance to Environmental Health & Safety (EHS) requirements
Support the site-wide Quality Department
Requirements:
Degree in Science or related discipline
Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
Experience in dealing with Regulatory Compliance desired
Good problem solving and investigation skills would be beneficial
An ability to work in a dynamic, fast-paced and goal driven environment
Be self-driven
Meticulous in attention to professional standards
Respond well to time constraints
Good professional standards and demonstrates good attention to detail
Ability to work under pressure and meet deadlines
Highly motivated self- starter and team worker
Ability to work in a team-based environment and ability to manage a wide range of specific tasks
Excellent organisational, coordination and communication skills