PE Global is currently recruiting a Quality Specialist for a 11 month contract, with a leading multi-national client based in SwordsThere are two open positions, one day's role and one shift role (4 x 12 hour extended days followed by 4 days off) 7am to 7pm.The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.Duties of the role/ResponsibilitiesResponsible for review/approval of new and updated Master Batch Records / Electronic Batch RecordsReview and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company proceduresProvides presence on the shop floor to support compliance and data integrityReview and approve new and updated SOPs/ Work Instructions and Controlled Job AidesActively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolutionQA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validationParticipates as the quality member on cross functional projectsSupport sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration ProgramProvides support to internal audits and regulatory inspectionsCollaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plansDrive continuous improvement and utilise problem solving tools and MPS (Merck Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issuesEducation/ExperienceRequiredMinimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.Evidence of leadership skills coupled with good oral and written communication skillsUnderstanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related areaDemonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environmentPreferredQuality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documentsDemonstrated analytical aptitude, critical thinking skills and problem-solving skillsDemonstrated ability to upskill/coach othersExperience working on manufacturing shop floorFamiliarity with GMP documentation review and/or shop floor auditingInterested candidates should submit an updated CV.Please click the link below to apply, call Chloe on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***