Quality Specialist REF- NHBT39

We are seeking to recruit a Quality Specialist for a Dublin based biopharma multinational.  The successful candidate will support quality risk management and compliance activities ensuring compliance, safety and reliable supply to customers.



·       Lead the QRM activities required for the NPI capital projects

·       Act as QRM facilitator and Risk lead for project QRAs

·       Schedule the completion of project QRAs and track to completion including tracking to closure associated QRM CAPAs

·       Ensure linkage from the output of the QRAs to the Commissioning, Qualification and Validation strategies

·       Support the facilitation of site QRAs which are required for update as a result of NPI

·       Present QRAs for concurrence at Site QRM Council

·       Support for related Compliance deliverables in support of audits and inspection readiness

·       Support for Change Management activities

·       Provide compliance contribution to project teams and leads small projects

·       Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges


Qualifications and Experience 

·       Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)

·       Minimum 5+ years pharmaceutical and/or biotech industry experience in Quality/ Compliance / Validation related role

·       Experience in startup biotechnology and drug substance facilities a distinct advantage

·       Familiarity with Commissioning & Qualification lifecycle deliverables

·       Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements

·       Experience in Quality Risk Assessments, as a participant, risk lead or facilitator

·       Experience in change controls

·       Experience in project management with demonstrated problem solving capabilities and technical writing capability

·       Strong leadership and interpersonal influencing skills

·       Strong verbal and written communication skills with well-structured communication and presentation ability to various audience level


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