Qualified Person at Qcs Staffing in County Dublin, Ireland | Kablio

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Qualified Person

Employer undisclosedRole 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

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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

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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

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Training + Development

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Interview process

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Visa Sponsorship

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Security clearance

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