PE Global is currently recruiting for a Quality Systems Specialist for a client site in Dublin –
The role of the Quality Control (QC) System Specialist will provide quality support and expertise to the QC laboratory and ensure supply of quality pharmaceutical products in meeting the Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit plan. The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.
Our Quality Control group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The QC System Specialist operates as part of self-directed team in carrying out day to day function and assigning priorities.
The QC System Specialist participates in departmental initiatives on improved compliance and quality systems.
PRINCIPAL ACCOUNTABILITIES:
- The QC System Specialist assures compliance with all safety and environmental requirements.
- The QC System Specialist delivers a robust Quality Management System for Dublin Systems such as Waters© Empower and Labware© Global Laboratory Information Management System (GLIMS) to support a flexible, collaborate, multi-skilled teamwork environment.
- The QC System Specialist completes System activities such as:
- Raw Material / Excipient updates based of Quality System Changes requests.
- Drug Substance / Drug Product updates based of Quality System Changes requests.
- In Process / Cleaning Validation key changes updates to meet campaign start up deadline.
- Addition of any new products/processes/raw materials for Drug Substance / Drug Product.
- Manages projects relating to the upgrade or replacement of the current systems and directly co-ordinates the activities with managers and personnel in all the areas.
- The QC System Specialist updates Global Laboratory Information Management System (GLIMS) or Empower for all changes and addition of new requirements.
- The QC System Specialist reviews and approves key system quality deliverables including GLIMS reports, Change control on trackwise, deviations (DNs) and CAPAs in SAP.
- The QC System Specialist ensures that all system activities comply with cGMP, including acting as auditee for CQAC/Regulatory Bodies /third parties site inspection.
- The QC System Specialist provides second person review support for team members system documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.
- The QC System Specialist authors or revises standard operating procedures and System Guidelines.
- The QC System Specialist is responsible for making decisions within guidelines and policies which impact System QC projects.
SKILLS AND KNOWLEDGE:
Typical Minimum Education:
- At least a bachelor’s degree in chemistry, biological science, pharmacy, or related science field.
Typical Minimum Experience:
- Minimum five (3) years’ experience in laboratory, technical services, and/or quality position required.
- Experience in Static / Method Build in Waters© Empower and Labware© LIMS .
- Working knowledge of biologics analytical methods and specifications and Good
REPORTS TO:
QC Centre Of Excellence (COE) Lead
Interested candidates should submit an updated CV, marked for the attention of Audrey
audrey.mccarthy@peglobal.net or 00353 21 4297900
Apply on Linkedin
