Quality , Science, Pharmaceutical & Food

Associate Quality Specialist

  • Contract
  • Tipperary, County Tipperary, Ireland
  • 41996049

PE Global is currently recruiting an Associate Quality Specialist for a 11 month contract, with a leading multi-national Pharmaceutical client based in Co. Tipperary.

This is initially a 11month contract position.

Associate Quality Specialist supports day to day QA activities. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).

 

Duties of the role/Responsibilities

  • Participate as functional expert in the cross functional team that manages production right first time at Ballydine.
  • 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.

 

Education/Experience

  • 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@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***