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Qualified Person

Req # JR - 024413 Location Dublin, Leinster, Ireland Job Category Quality Control Date posted 07/16/2020

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Summary

  • The Qualified Person (QP) is responsible for undertaking the necessary training prior to application for inclusion as a Qualified Person on the Sandyford Compounding Facility Manufacturing License.
  • The QP is primarily responsible for release of Nutrition, Chemo and Antibiotic products the Sandyford Site.
  • They should oversight and quality assurance expertise and guidance of the compounding process in line with regulatory standards.
  • The QP must drive and support a culture of relentless compliance and continuous improvement and standardisation, ensuring compliance with the Manufacturing license, customer requirements and Baxter requirements.
  • The QP is responsible for the management of the release process (including the batch releaser activity), ensuring product meets specification and the customer order requirements prior to release and is released according to schedule.

Essential Duties and Responsibilities

  • Responding to pharmaceutical queries concerning compounded medicinal products from customers and Baxter’s homecare nurses
  • Support facility projects including process development and quality improvement initiatives
  • Becoming eligible for inclusion on the Manufacturing License as a Qualified Person
  • Ensure products and processes comply with procedures and the principles of GMP
  • Liaising with the Batch releasers responsible for chemo and Antibiotic product release
  • Liaising with Dispatch and customer service to manage quality issues and timely customer service
  • Supporting the preparation of Deviation and QA trend reports
  • Supporting the preparation of Key Performance Indicators (KPIs)
  • Supporting investigation of customer complaints / quality defects
  • Perform quality review of orders prior to manufacture
  • Development of quality system procedures, controlled documents and processes
  • Review and investigation of deviations and reject / scrap reports and the implementation of corrective and preventative actions
  • Supporting and coordination and performance of corrective and preventive action investigations (CAPA’s)
  • Review of process change controls
  • Review of validation protocols and reports
  • Provide support to the site wide Quality Department
  • Assist in the internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
  • Performance ansupervision of recall assessment.
  • Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
  • Training of Quality and Manufacturing personnel
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
  • Maintenance of professional status and standards

  • Quality System Management and Review
  • Responsible for the completion of the Quality Management Review meetings and the Annual Product Quality Review
  • Ensure outcomes, decisions and actions of the review are documented
  • Ensure meeting actions are completed to agreed deadlines

  • Audit Management
  • Ensuring site-wide local systems are in compliance with Baxter Corporate and Regulatory requirements
  • Ensures the site has a process for internally reviewing the compliance status and is prepared for an audit at any time
  • Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit

Qualifications

  • QP Qualification
  • Pharmacy Degree (or equivalent) in science-related discipline essential
  • Previous experience in a pharmaceutical company or equivalent-type role. Ideally a minimum of two years experience in a GMP regulated aseptic environment.
  • Experience/qualifications in microbiology/environmental monitoring a distinct advantage
  • Good problem solving and investigation skills
  • Good professional standards, meticulous 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
  • Good organisational, coordination and communication skills
  • Flexible Highly
  • Motivated
  • Team Player

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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