APC Ltd
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Quality Specialist - VLE Therapeutics
Location:
Dublin, Co. Dublin
Description:
Quality SpecialistAbout VLE TherapeuticsPowered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support GMP clinical manufacturing of advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients. This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines. To create the best client experience, we will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments. 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 AgreementsSupplier GxP monitoring during onboarding and throughout lifecyclePerform 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 processesQA SME for Quality Risk Management activities including leading and, where appropriate, facilitating QRM activities in line with ICH Q9 rev1Support 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. Experience & QualificationsEssential At least 3 -5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systemsPrimary Degree in scientific discipline or equivalentAbility to work independently and flexibility within a start-up organization and to influence a high-performance Quality culture Desirable Regulatory experience an advantageProven ability to manage competing priorities and timelines and to make decisionsQuality Risk Management experience an advantage, in particular experience in leading or facilitating QRM activitiesExperience in Supplier Quality oversight activities an advantageKnowledge of Cell and Gene therapy manufactureGood interpersonal skills with the ability to influence others across multiple functions How to apply:Suitable applicants should submit a CV and Cover Letter. Please note that the closing date for applications for this position by 29th of April 2024VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.
Company:
APC
Posted:
April 12 on HireLocker
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More About this Listing: Quality Specialist - VLE Therapeutics
Quality Specialist - VLE Therapeutics is a Quality Assurance Quality Specialist Job at APC located in Dublin D. Find other listings like Quality Specialist - VLE Therapeutics by searching Oodle for Quality Assurance Quality Specialist Jobs.
Quality Specialist - VLE Therapeutics is a Quality Assurance Quality Specialist Job at APC located in Dublin D. Find other listings like Quality Specialist - VLE Therapeutics by searching Oodle for Quality Assurance Quality Specialist Jobs.