Associate Quality Specialist – Tipperary

PE Global are currently recruiting for a Quality Specialist on behalf of our client in Tipperary:

6 Month Fixed Term Contract

Ideal candidate will have 2 years’ experience, however, for this role due to the urgent requirement we will look at strong new graduates. We are looking to commence asap candidates with no, or shorter notice periods only please.

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

POSITION RESPONSIBILITIES

• 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.

COMPETENCIES

• 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.

Skills:

• 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.

Interested candidates should send their CV to Audrey.mccarthy@peglobal.net