Quality Specialist

4 weeks ago

Cluain Meala, County Tipperary, Ireland Quanta part of QCS Staffing Full time
Overview

Quality Specialist - Life Science - 11-Month Contract - Clonmel. Our partner in the Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan. They require a Quality Specialist to support them at their facility in Clonmel.

Responsibilities
  • 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.
  • Creation, review and approval of quality procedures as required.
Qualifications
  • 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.

Are you a good fit for a Quality Specialist? Get in touch with us today.

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