PE Global is currently recruiting for a Quality Specialist for a leading multi-national Pharma client based in South Tipperary.
This is a contract position.
Role:
• Participate as functional expert in the cross functional team that manages
production right first time at site.
• 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.
Requirements:
• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• 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.
• 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***