Quality Assurance Specialist Shift

Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist (Shift) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Shift Pattern: This is a shift position – 4 cycle 12 hours per shift e.g 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 JOB DESCRIPTION & SPECIFIC OBJECTIVES The Quality Assurance Specialist within Our Company is required to Work a 4-shift pattern role 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. REPORTING STRUCTURE Reports to Quality Manager QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Skills and Knowledge Typical Minimum Education Bachelor’s Degree or higher preferred in a Science discipline Typical Minimum Experience 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 People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.