QA Specialist II GMP (12 Month Contract ) Cork, Jobs, 501

QA Specialist II GMP (12 Month Contract ) - Cork

Contract / Temp
€28 - €36 per hour DOE
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Our client, a Multinational Biopharmaceutical company, are currently seeking an experienced and proactive QA Specialist to provide support within the GSIUC QA Department, this is a 12-month contract role based in Cork.

This role is within the GSIUC QA Department, under the QA Quality Systems team, duration of 12 months. This specific role is required to perform activities in relation to supporting updates for quality systems processes such as deviations, change controls and QRM; drives improvements to the QMS processes; QA Review & Approval of Deviations/Change Controls/Procedures.




  • Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
  • Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.
  • Giving site training on QMS elements such as GMP Induction and GMP refresher.
  • Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/ Deviations/Change Controls and other types of controlled documents.
  • Participates within inter-departmental and cross-functional teams.
  • Working directly with personnel to drive improvements to the QMS processes.
  • Performs metric gathering and critically assesses the data for emerging trends.
  • Participates in internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP.
  • Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
  • Work on upcoming projects within the QA Systems team.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Normally receives very little instruction on routine work, general instructions on new assignments.


Professional Experience & Qualifications:


  • A BS or BA and a least 4 years of relevant experience in a GMP related field.
  • A MS and a least 2 years of relevant experience.
  • Prior experience in pharmaceutical industry is preferred (ideally within this QA role).
  • Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
  • Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and packaging requirements.
  • Previous experience with change management and validation documentation is advantageous.
  • Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
  • Demonstrates audit and investigation skills, and report writing skills.
  • Demonstrates strong verbal, technical writing, and interpersonal skills.
  • Proficiency in MS Office applications.



Contract (12 Months), Full time, Hybrid - 2 Days On -site 3 Days Remote, Monday-Friday, normalised office hours



€28 - €36 per hour DOE 

For a confidential discussion on this or any other current opportunities please contact Mark Farrell