Quality Specialist

4 days ago

Dublin, Dublin City, Ireland Scientificjobs Full time

Quality Specialist (Shift)
RK23756
11 Months
Dublin

We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

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.

Key Responsibilities:

Responsible 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 toolsParticipate in continuous improvement initiatives to enhance operational efficiency and resolve issuesEducation and Experience:

Bachelor degree in a scientific or engineering fieldMinimum 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.Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents

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