QA Compliance Specialist

Desired Skills: compliance,material management,qa

PE Global is currently recruiting for a Snr Specialist, QA Compliance Materials Management on behalf of our client based in North Dublin:

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

Key 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:
o Change controls
o Deviations/Investigations
o Supplier Investigations
o CAPAs
o Supplier Change Notifications (SCN)
o TSE (Transmissible Spongiform Encephalopathy) Certificates
o 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.

Qualifications & Experience
The successful candidate must possess:
• BSc in Science or related discipline with a minimum of 3 years’ 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.
• Employees are expected to display the Biopharma Behaviors, which enable them to be successful and perform at their highest level.

Interested candidates should submit an updated CV.

To apply, please call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@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***