Quality , Science, Pharmaceutical & Food

IQA Specialist – South Dublin

  • Contract
  • Remote
  • Dublin South
  • 41949460

PE Global are currently recruiting for An IQA Associate  for a client site in South Dublin  –

The role:

PE Global is currently recruiting for a Quality Assurance Associate on behalf of our client based in Dublin. This is an initial 12-month contract role.

Job Description:
The Associate in Quality Assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. The Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.

Responsibilities:

  • Testing of primary and secondary components for use in the manufacture of aseptic products.
  • Sampling of Excipients and Drug Substance under Grade C conditions.
  • Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
  • Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
  • Provide training and advice to staff in relation to testing of components and packaging.
  • Actively participate in audits and their preparation.
  • Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
  • Write, review and approve Standard Operating Procedures in accordance with Policies.
  • Perform all activities in compliance with safety standards and SOPs
  • Support continuous improvement and Operational Excellence initiatives

 

Education & Experience:

  • Must Pass Eye-Tests for Visual Inspection
  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.

 

 

Interested candidates should submit an updated CV.

 

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

 

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