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Quality Assurance Specialist

  1. Ireland, East
Ireland
  1. Contract
Competitive
  1. CAPEX Projects
36269
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Quality Assurance Specialist - South-East, Ireland - 11 Months Contract

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Quality Assurance Specialist.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, and master data using the site systems.
  • Review and approval of SOPs, cleaning verification/validation data, and other documents as necessary for the IPT department.
  • Drive effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems.
  • Support the development and implementation of improved quality reporting measures.
  • Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to the batch manufacturing process.
  • Work collaboratively to drive a safe and compliant culture.
  • Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
  • Provide effective real-time on-the-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
  • Provide quality input into the decision-making process on the shop floor ensuring that product quality is maintained.
  • Provide training in all aspects of Quality Management Systems and GMP.
  • Ensure all work is carried out in line with SOPs, training, or other quality systems such as change controls where applicable.
Desirable Experience:
  • Third Level Degree qualified in a Science/Technical or related discipline.
  • Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
  • GMP Audit experience in the pharmaceutical industry
  • Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognise potential compliance issues and trends.
  • Communication, decision making, people influencing, and project management skills will be important. 
  • Report, standards, policy writing skills required.
If this role is of interest to you, please apply now!
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