Qualified Person at Qcs Staffing in County Dublin, Ireland | Kablio
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Qualified Person
Employer undisclosed
Role managed by a recruiter
Oversee QA/QP procedures, IMP release and regulatory compliance for a large pharma facility
8 days ago ago
Experienced (8-12 years), Expert & Leadership (13+ years)
Contractor
County Dublin, Ireland
Onsite
Your recruiting firm
Founded with the aim of providing top-tier staffing solutions for diverse sectors.
Focus on long-term partnerships with clients, ensuring the right talent for specialized roles.
Expert in recruiting for both large-scale projects and niche, high-demand sectors.
Has become a trusted partner in sectors such as Industrial, Energy, and Infrastructure.
Notable for a rapid response to market demands and changing industry trends.
Experience in delivering recruitment services for large infrastructure and energy projects.
Specializes in sourcing skilled professionals for both permanent and temporary roles.
Recognized for working on complex and large-scale projects with a diverse client base.
About the client
About the client
Information not given or found
Role
Description
imp release
risk assessment
regulatory liaison
document approval
audit support
team supervision
Perform QP release of Investigational Medicinal Products (IMPs) in line with regulatory requirements.
Identify risk areas and contribute to global audit planning.
Influence external regulatory environment through interactions with authorities and industry groups.
Ensure rapid communication of significant quality issues to senior management.
Review and approve QA/QP procedures, training materials, and Quality Agreements.
Support start-up activities, including Manufacturer/Importation Authorisation submissions and knowledge transfer.
Maintain Site Master File and oversee Manufacturer/Importation Authorisation updates.
Review and approve procedural documents and participate in cross-functional teams.
Advise stakeholders on quality issue management and process improvements.
Provide guidance during Health Authority GMP/GDP inspections and audits.
Supervise QA personnel and champion continuous improvement initiatives.
Requirements
eu qp
science degree
biopharma
ich/gmp
leadership
communication
Excellent communication and stakeholder engagement skills.
Proven leadership and influence management skills in a global matrix environment.
Eligibility to act as EU Qualified Person under Manufacturing/Importation Authorisation.
Degree in science, engineering, or related discipline.
Extensive experience in biopharmaceutical/pharmaceutical industry quality roles.
Experience with QP release of IMPs (preferred) and Responsible Person on WDA (desirable).
Strong knowledge of ICH/GMP, data integrity, regulatory guidelines, and clinical supply chain processes.
Benefits
Information not given or found
Training + Development
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Interview process
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Visa Sponsorship
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Security clearance
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