Associate Quality Specialist

Orion Group Life Sciences are currently recruiting an Associate Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend.

POSITION RESPONSIBILITIES

• Participate as functional expert in the cross functional team that manages production right first time.
• 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 change 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.
• Review and approve batch, cleaning and testing documentation.

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, Document Management Systems).

• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.