Quality Assurance Specialist

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

This is a shift position – 4 cycle 12 hours per shift e.g Shift premium is 33%
• Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights
• Week 2- short week: Wed and Thurs Days,
• Week 3: Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
• Week 4: short week: Wednes and Thurs Nights

The Quality Assurance Specialist within Our Company is required to:
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Work well cross functionally and be an active team member

POSITION RESPONSIBILITIES
• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding of sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

Skills and Knowledge
• Bachelor’s Degree or higher preferred in a Science discipline
• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable Technical
• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
• Competent in the use of MES and SAP


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.