Beschreibung
There is an open opportunity for a Quality Coordinator to join the Quality Compliance department at GSK Barnard Castle. This role will have you working within either the Regulatory Conformance team or Technical Terms of Supply (TTS) team.
Within the Regulatory Conformance team you would take responsibility for maintaining regulatory compliance ensuring that every product manufactured at Barnard Castle is produced in accordance with market licences and regulatory requirements. Through development within the role, you will build your knowledge on regulatory authority guidance in relation to Chemistry Manufacturing Controls (CMC), new product introduction and regulatory compliance to support the manufacture of GSK products that comply with quality, safety and efficacy requirements.
Within the Technical Terms of Supply team your role would be to collate, produce, issue and maintain to schedule Technical Terms of Supply documents and Quality Assurance Agreements in compliance with Quality Management System requirements for commercial materials and products. Through development within the role, you will build and manage business relationships with internal and external customers, resolve issues and interpret and advise on TTS requirements for projects, new ways of working and market requirements.
Basic Qualifications
- Degree qualified ideally in Chemistry, Microbiology, Pharmacy or a related scientific subject
- Understanding and ability to apply GxP principles
- Experience in manufacturing processes and/or laboratory testing
Preferred Qualifications
- Knowledge of regulatory guidance and pharmacopoeia
- Familiarity with managing changes in processes and systems
- Awareness/experience of new product introduction
- Experience with SAP/M-ERP
- Good communication skills and attention to detail