Quality Specialist REF- NHBT39


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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.
Responsibilities
· 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