QA Specialist at Qcs Staffing in Dublin, County Dublin, Ireland | Kablio

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QA Specialist

Employer undisclosedRole managed by a recruiter

QA Specialist for biopharma IMP release, QA support, regulatory compliance.

12 days ago ago

Experienced (8-12 years), Expert & Leadership (13+ years)

Contractor

Dublin, County Dublin, Ireland

Onsite

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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

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Role

Description

mia management

qa oversight

use extension

quality agreements

product specs

batch release

Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)
Provides Quality Assurance support in the Use Date Extension process.
Support the generation and ongoing maintenance of Quality Agreements.
Generates and maintains Product Specification Files (PSF) for IMP.
Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
Provides QA support and oversight of packaging and labelling operations for IMP.

Requirements

ich/gmp

data integrity

regulatory

science degree

3 years

communication

Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
Excellent communication, presentation and critical thinking skills are essential.
Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.
A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry

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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