Excellent opportunity to join a Dublin based pharmaceutical start up as a Quality Specialist. This role offers great scope to get involved in digital led manufacturing of vaccines and therapeutics. This role won't be around long, so please apply today and I will be in touch if your profile is a good fit. This role is based in South Dublin.

Principal Responsibilities

• Responsible for Quality oversight, with Management support, of on-site manufacturing operations, internal materials management, warehousing operations, and quality control testing activities.
• Responsible for Quality oversight, with Management support of operational activities which occur at approved outsourced service providers (QC testing, material storage, material supply, cleanroom etc).
• Preparation and review of Quality Agreements
• Supplier GxP monitoring during onboarding and throughout lifecycle
• Perform batch documentation review, QA SME for key Quality systems including change control, complaints, deviations, validation, quality risk management and product annual reviews related to manufacturing operations and GxP processes
• QA SME for Quality Risk Management activities including leading and, where appropriate, facilitating QRM activities in line with ICH Q9 rev1
• Support the QA leadership and QP team in relation to preparation and review of the relevant documentation for release activities.
• Provide oversight to continuous quality system improvements and support implementation of improvements in GxP Compliance, Preventive Maintenance, Deviation Management, Change Control Programs and other GxP Systems.
• Provide QA and compliance support to projects impacting manufacturing activities.
• Provide support and expertise for inspection readiness activities, regulatory inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Responsible for quality review and approval of Master Batch Records in accordance with our internal procedures and GMP principles.

Experience & Qualifications

Essential

• At least 3 -5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems
• Primary Degree in scientific discipline or equivalent

Desirable

• Regulatory experience an advantage
• Proven ability to manage competing priorities and timelines and to make decisions
• Quality Risk Management experience an advantage, in particular experience in leading or facilitating QRM activities
• Experience in Supplier Quality oversight activities an advantage
• Knowledge of Cell and Gene therapy manufacture
• Good interpersonal skills with the ability to influence others across multiple functions