Job Description

Snr Specialist, QA Compliance Materials Management

An opportunity for has arisen to recruit a QA Compliance Snr Specialist within the Materials Management team of a Dublin based Biotech multinational

The successful candidate 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.

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 Other associated documentation

• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & 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.

For more information and a full job spec contact Nicola on (phone number removed) or email your CV to (email address removed)