QA Specialist

Posted 20 February 2023
Salary Negotiable
Job type Temporary
DisciplineLife Science
Contact NameSarah Walsh

Job description

Orion Group Life Sciences are currently recruiting a QA Specialist for one of our Multinational Biopharmaceutical clients based in Cork for an initial 12-month contract.

The QA Specialist is required to perform activities in relation to supporting updates and site 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.

This position requires a sound knowledge of quality assurance systems, methods, procedures, critical thinking, and excellent communication skills. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.


  • 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 refreshers.
  • 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.
  • Work 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.

Knowledge, Experience and Skills:

  • Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
  • Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems).
  • Demonstrates working knowledge of quality assurance systems, methods, and procedures.
  • Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
  • Demonstrates investigation skills, and report writing skills.
  • Good verbal, written, and interpersonal communication skills.
  • Proficiency in Microsoft Office applications.

Education and Experience:

  • 4+ years of relevant experience in a GMP environment related field and a BS.
  • 2 + years of relevant experience and a MS.

If you are interested in having a confidential discussion regarding this opportunity, please reach out to Sarah Walsh on for further details.

#Oriongroup #Orionlifesciences #Oriongrouplifescienceseurope #QASpecialist #Multinational #Contractopportunity

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.