QA Specialist

Overview

QA Specialist ensuring GMP compliance and batch release for clinical trial IMPs.

Key Responsibilities

• product specs
• qa oversight
• mia management
• batch release
• quality agreements
• packaging ops

Tasks

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

Requirements

• communication
• critical thinking
• science degree
• 3 years
• ich/gmp
• data integrity

What You Bring

-Excellent communication, presentation and critical thinking skills are essential. -A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry -Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance -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.

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About Qcs Staffing

-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.

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