QA Specialist - Carlow - Shift

PE Global is currently recruiting a QA Specialist on behalf of our client based in Carlow: 11-month initial contract- Shift (4 cycle) The Quality Assurance Specialist within Our client 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 ( EBRs ) / 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. QUALIFICATIONS&EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Skills and Knowledge Typical Minimum Education Bachelors 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 The position is onsite and remote or hybrid is not applicable for this role, 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: Wednesday and Thurs Nights Shift premium is 33% For the job shift experience, working in a quality function or in an aseptic environment is beneficial Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: batch documentation packaging productionTPBN1_IJ