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QA Senior Specialist

  1. Dublin
County Dublin
  1. Contract
Competitive
  1. CAPEX Projects
02-04-2024
33557
QA Senior Specialist - Pharma -  Dublin - 12-Month Contract 

One of the top 10 best companies to work in Ireland is looking for more engineers for their large-scale new facility north of Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.


Responsibilities include, but are not limited to, the following:
  • Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements. This includes:
    • Building and maintaining a good working relationship with the contractor
    • Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation, etc.
    • Recommending quality related improvements to the contractor
    • Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
    • Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.

Required Competencies
  • In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
  • Ability to assess the right balance between business targets and scientific and quality decisions
  • Strong analytical and problem solving skills
  • Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate
  • Good communication and organisational skills
  • Project management skills
  • Development, organisation, and execution of the Pharmaceutical Quality System of BMS within the Global Quality Organisation
  • Must have computer proficiency

If this role is of interest to you, please apply now! 

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