Senior Quality Assurance

Senior Quality Assurance - Dublin - Contract

This exciting contract role is based on an 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 in Dun Laoghaire, 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.
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Vial Fill line project

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

Requirments 

• Provide overall quality direction and oversight for 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, IQ, OQ, PQ and associated validation documents
    • Review of executed validation documents and reports
• Perform all activities in compliance within safety standards and SOPs 
• Ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations.

Qualifications 

• University degree. Science or Engineering related discipline preferred. 
• Relevant experience (10yrs +) 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
• Ability to work independently and remotely with minimum direct supervision.
• Critical thinking skills.
• Strong organisational, communication, coordination, and meeting facilitation skills.
• Independent, self-motivated, organized, 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 is of interest, please apply now.

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

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