Quality Specialist - VLE Therapeutics
APC
- Dublin
- Permanent
- Full-time
- 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.
- Review and approval of VLE Therapeutic's Standard Operating Procedures and controlled documents.
- Define. Meet and drive standard quality KPIs and review quality indicators with recommendation for actions for improvement in relation to packaging operations.
- 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
- Ability to work independently and flexibility within a start-up organization and to influence a high-performance Quality culture
- 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