QA Specialist

IrishJobs

Carlow, Carlow, Ireland

Carlow, Carlow, Ireland

Trouver des emplois similaires

À propos

An amazing opportunity to work in the Quality field as a Quality Assurance Specialist at a leading pharmaceutical company. Responsibilities: 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 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. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS 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 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 Skills: QA SAP

TLNT1_IJ

Carlow, Carlow, Ireland

Compétences linguistiques

English

Avis aux utilisateurs

Cette offre a été publiée par l’un de nos partenaires. Vous pouvez consulter l’offre originale ici.

Trouver des emplois similaires