QA Specialist II ( 12 Month Contract) Dublin, Jobs, 494

QA Specialist II ( 12 Month Contract) - Dublin

Dublin (North County)
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 support their operation to ensure compliance with applicable regulatory requirements in relation to Wholesale Distribution Operation.

This is a 12-month contract role based onsite in Dublin. 




  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements in relation to Wholesale Distribution Operation.
  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Distribution Practice (GDP) and Marketing Authorisations.
  • Supports the Responsible Person (RP) on site as well as working cross-functionally with warehouse and customer service personnel as well as Facilities, EHS and Validation colleagues.
  • Supports site operations from a QA perspective.
  • Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.
  • Reviews shipping records, environmental monitoring and associated data relating to distribution activities.
  • Works directly with operating entities to ensure that internal audits on site are conducted on a continuing basis to ensure compliance to GDP requirements.
  • Participate in preparation for and during internal and corporate audits as well as regulatory inspections of the site.
  • Participates in the development & delivery of training programs regarding relevant to site operations.
  • Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to site operations.
  • Conducts gap analyses and supports risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards,
  • Participate in local and corporate projects and process improvement initiatives, as required.


Professional Experience & Qualifications


  • Required Degree or Certification: BS desirable.
  • 3 years of relevant experience in a GXP environment related field.
  • Demonstrates proficiency in Good Distribution Practices (GDP).
  • Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical materials would be beneficial.
  • Experience in root cause analysis and deviation/CAPA support and review
  • Knowledge of current Good Manufacturing Practices (GMPs).
  • Excellent Communication & Interpersonal skills
  • Exemplary attendance and time-keeping record
  • Excellent Computer Skills





Contract – 12 Months. Normalised office hours. Site Based.




€28 - €36 per hour DOE


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