QP / QA Specialist

Science & Pharmaceutical
Science & Pharmaceutical
Sligo
Permanent
15949
Sligo
Permanent
15949

QP/ QA Specialist

We are now recruiting a QA/QP Specialist for a start-up Biologics site. In this role, you will take ownership for the disposition of bulk products manufactured at the site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.

Key responsibilities:

  • Ensure that products manufactured meet requirements of end-users, Regulatory Authorities, and the company.
  • Review and maintain adherence to manufacturing and testing processes including validation, production conditions, and manufacturing records.
  • Oversee any deviations or planned changes in production or QC and ensure authorization is in accordance with defined systems and relevant authorities. 
  • Confirm that all necessary checks and tests have been performed, including that all additional sampling, inspection, etc. have been initiated due to deviation or planned change.
  • Inspect all necessary production and QC documents to ensure they have been completed and endorsed by authorized team members.
  • Ensure all audits have been carried out as required by the quality assurance system.
  • Account for all factors relevant to the quality of the batch taking necessary action when appropriate.
  • Maintain knowledge and experience of all technical and scientific progress and changes in quality management relevant to the products including requirements to certify an unfamiliar batch of product type such as a new product range being introduced prior to certification.
  • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
  • Drive team compliance to procedures, policies, and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines at all times.

Education & Experience:

  • Third level qualification in a scientific discipline with 5 years' experience in the pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or a similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
  • 5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
  • Desirable: 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.
  • Experience assessing day to day quality issues across products and processes.
  • Strong decision making and the ability to work with autonomy.

The role is very well remunerated with an excellent benefits package and ample career development opportunities within this large multinational group.

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For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071 9140251



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Your Consultant
Davin Ferguson
Principal Recruitment Consultant