Quality Specialist - Packaging

€45,000 - €70,000 yearly
  • Force Recruitment & Outsourcing
  • Tipperary, Ireland
  • 12/09/2023
Contract QA - Quality Control

Job Description

We are currently recruiting for a Quality Specialist for a Biopharmaceutical Manufacturer in Co. Tipperary. The Quality Specialist supports day to day QA activities in the facility. 


  • Participate as functional expert in the cross functional team that manages production right first time.
  • Review and approve batch, cleaning and testing documentation.
  • Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
  • Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
  • Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
  • Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
  • Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
  • Ensure changes controls raised are documented, assessed and completed.
  • Prepare Annual Process and System Reviews.
  • Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
  • Participate in the generation and communication of quality metrics.
  • Creation, review and approval of quality procedures as required.


  • Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
  • Team Work: Interacts with people effectively. Able and willing to share and receive information.
  • Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
  • Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
  • Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
  • Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self direction.


  • Degree or post-graduate qualification in Science, Pharmacy or equivalent.
  • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
  • Spray drying experience desirable.
  • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  • Experience and knowledge of GMP Requirements for Electronic /paper free operations.
  • Experience in High potency manufacturing desirable.

KEY Competencies

Degree or post-graduate qualification in Science, Pharmacy or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).