Quality Systems Specialist

The role:

PE Global is currently recruiting for a Quality Systems Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract role.

Job Purposes:

• The Quality Systems Specialist is responsible for maintaining and continuous improvement of the Quality Management System throughout their knowledge and areas of expertise.

Responsibilities:

• Provide quality support to the project and site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
• The main areas of expertise are, but not limited to, specific tasks and roles such as: deviation management, change control management, quality systems management, document / SOP management, GMP training & knowledge management.
• Ensure the health & wellbeing of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs
• Serve as support for metrics management for site deviation management and change control systems.
• Support the review and approval of site deviation and investigations reports.
• Support the site change management process.
• Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Day to day management of Deviation CAPA and Change Control metrics
• Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
• Liaise directly with cross-functional departments to ensure that change control and deviation management system requirements are met
• Support Regulatory and Compliance Inspections at the site as required
• Support for management of recalls as required
• Comply with Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Build a Quality culture that delivers unconstrained supply, Right First Time to our patients.

Education and Experience:

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
• 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
• Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
• Experience with new product introductions and/or process qualification/technology transfer.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***