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QA Specialist – VLE Therapeutics (Full Time)

Dublin, Ireland

Description

QA Specialist – VLE Therapeutics 

About VLE Therapeutics 

Powered 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 the GMP manufacturing of clinical and commercial vaccines, next generation biologics & 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 a Molecule-2-Market accelerator.

Stage 1 - At our current APC facility, we are constructing a new state of the art biomanufacturing facility. Operations will employ cutting edge technology including single use equipment & disposables and deploy digital solutions to support the best client experience.

Stage 2 - In parallel, we are planning the development of a bespoke 80,000ft2. 

greenfield GMP manufacturing facility, which will provide a world-class platform for the manufacture of a wide range of vaccines next generation biologics & advanced therapeutics for our clients globally.

Key to enabling our strategy is to create the best culture, the right values & behaviours and as a result, the establishment of a high performing team committed to creating a culture of excellence in everything we do. 

Position Summary

The QA Specialist will be responsible, with management support, for providing oversight of quality activities associated with the GMP Manufacturing activities in VLE Therapeutics. This will include the responsible for quality oversight of the storage, incoming materials, manufacturing and testing activities related to the internal manufacturing facility and external outsource service providers ensuring that operations comply with all applicable GMP guidelines and regulations. This responsibility includes the oversight of the company’s QMS to ensure that quality and compliance requirements are followed in line with the business needs.

Principal Responsibilities

  • Responsible for Quality oversight, with management support of internal materials management, warehousing operations, manufacturing and quality control testing activities which occur onsite.
  • Responsible for Quality oversight, with management support of operational activities which occur at approved external outsource service providers (QC testing, material storage, etc).
  • Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews related to manufacturing operations.
  • 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 compliance, Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Provide QA and compliance support to projects impacting on manufacturing activities.
  • Provide support and expertise for inspection readiness activities, during health authority 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 and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to packaging operations.

Qualifications

  • At least 5 years’ experience in cGMP Pharmaceutical Operations is essential.
  • At least 5 years’ experience in Drug Substance Biologics manufacturing is essential.
  • Vaccine manufacturing experience is preferable.
  • Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
  • Aseptic operations experience is preferable.
  • The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.           
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • Demonstrated success records in auditing and improvement processes is preferable.
  • Ability to operate efficiently in a complex matrix organization
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • Efficient in relevant GMP systems (QMS, CMMS, ERP, etc).

Education

  • Degree in scientific discipline or equivalent

How to apply

Suitable candidates should submit a CV and a Cover Letter 

VLE 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.

 Similar vacancies arising in the coming 6 months may be filled from this group of applicants.

 

Salary

Negotiable