QA Specialist

The role:

PE Global is currently recruiting for a QA Compliance & Systems Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12-month contract role.

Position Summary:

Reporting to the Senior Manager, QA Compliance Materials Management, the Specialist will support the material qualification and release activities for the new commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline.

Responsibilities:

• Preparation, review and approval of Material Qualification Documentation.
• QA disposition of raw materials, level 1 & level 2 consumables.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
• Change controls
• Deviations/Investigations
• Supplier Investigations
• CAPAs
• Supplier Change Notifications (SCN)
• TSE (Transmissible Spongiform Encephalopathy) Certificates
• Other associated documentation
• Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Education & Experience:

• BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Knowledge of material qualification & SAP would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.

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***