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QA CQV Specialist

  1. NI & Ireland
  1. Contract
  1. Compliance / Quality Assurance
Date Posted12 Apr 2021
QA CQV Specialist - Ireland - 18+ month contract

A fantastic long-term contract opportunity focusing on delivering a new vial filling line. You'll be joining the Quality team with an overview of CQV activities. 

QA CQV Specialist
Dublin, Ireland
18+ Month Contract

Quality Assurance CQV Specialist
The facility is a 35,000 + square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within the facility to strive for solutions that improve health outcomes and dramatically improve people’s lives. The client is developing the capability to produce all its medicines at the site in Dublin, helping to ensure continuity of supply of our medicines as we expand internationally.

The site has state of the art working facilities, including Next Generation office areas and on site GYM. In addition the client will provide flexible working conditions, including flex hours and work from home.

Vial Fill line project:
The client will be building a new Vial filling line including vial washer, depyrogenation tunnel, filtration skid, new Isolator, new clean room and associated upgrades / tie-ins to clean utilities

Role Responsibilities:
  • Provide QA support and oversight for CQV activities associated with the above ‘Vial fill line project’
  • Quality review and approval of C & Q documentation
  • Review of Risk Assessments, DS, URS & QRAES documents
  • Review of validation Plans, Protocols, FAT, SAT, IQ, OQ, PQ and associated validation documents
  • Review of executed validation documents and reports
  • Perform all activities in compliance with safety standards and SOPs 
  • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. 
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role 
Qualification Requirements:
  • Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new Fill line / Isolator
  • University degree. Science or Engineering related discipline preferred.
  • Ability to work independently and remotely with minimum direct supervision.
  • Critical thinking skills.
  • Strong organisational, communication, coordination, and meeting facilitation skills.
  • Independent, self-motivated, organised, able to multi-task in project environments and skilled in communication and collaboration.
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
If this role interests you, apply today! 

The candidate must have the rights to work in the location stated in the job advert.

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