The Qualified Person (QP) is responsible for undertaking the necessary training prior to application for inclusion as a Qualified Person on the Dublin Compounding Facility (DCF) Manufacturing Licence.
ESSENTIAL DUTIES AND RESPONSIBILITES
The QP is accountable and responsible for the following activities, as relevant:
- 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 DCF Manufacturing Licence as a Qualified Person
- Qualified Person (QP) supervision of the Quality (Deputy) Batch Releasers of products manufactured in the DCF as per EU Directives, Manufacturing Authorisation and EU GMP
- Co-ordinating the Quality (Deputy) Batch Releasers to ensure timely release of product; and the inspection and release of Product, as required
- Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs's, change controls, Regulatory Authority Inspections and Product Complaints and the use of unlicensed drug components.
- Review and investigation of NCRs and reject / scrap reports and implementation of corrective and preventative actions
- Awareness of complaint and quality defect investigations.
- Performance and supervision of recall assessment.
- Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
- Maintenance of Merlin Component Files, Finished Product Codes and review of drug admixture stability and assignment of shelf-lives
- Overview of regulatory/guidance and legislative updates relevant to Baxter
- Training of Quality and Manufacturing personnel
- Review of quality documentation. QA data review and compilation of reports Development of quality system procedures, controlled documents and processes
- Risk Management of the quality system and processes
- Support the site wide Quality Department
- Maintenance of professional status and standards
- Develop a culture of continuous quality improvement within Baxter
- Ensuring site-wide local systems are in compliance with Baxter Corporate and Regulatory / GMP requirements
- Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
- Compliance to Environmental Health & Safety (EHS) requirements
- Refer to BaxWho for organisational structure
EDUCATION AND/OR EXPERIENCE
- Previous experience as a Qualified Person
- Risk Management
- Working in a project based environment
- Experience of implementing changes and process development
- Previous experience in an aseptic manufacturing facility
- Good Supervisory skills. Good interpersonal and people / team management skills.
- 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
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.