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Proclinical is seeking a Quality Associate to support quality assurance activities within a GMP environment. This role involves ensuring compliance with cGMP standards, supporting the release of GMP-relevant documents and batches, and contributing to departmental projects. You will play a key role in maintaining quality standards and supporting project-related initiatives.
Job Responsibility:
Review and manage GMP-relevant documents and batch records to ensure compliance
Provide functional expertise and support to teams within the quality assurance unit
Contribute to the development and implementation of quality tools, processes, and initiatives
Support project-related activities such as product portfolio development, quality risk assessments, training, and facility upgrades
Ensure adherence to internal and external quality and safety guidelines, including cGMP, SOPs, and regulatory requirements
Manage incoming documents, including executed batch records and vendor labels
Facilitate the timely release of GMP batches, labels, and investigational medical products
Organize, scan, file, and archive QA-owned documents, such as certificates of compliance and batch review checklists
Requirements:
Strong communication skills to address GMP and logistics-related queries effectively
Knowledge of scientific, technical, and regulatory aspects relevant to quality assurance
Familiarity with drug development processes and cGMP guidelines
Basic understanding of safety and environmental regulations
Good organizational skills to manage documentation and project timelines
Proficiency in English, both written and oral, with fluency in the site language preferred
Must have the right to work in this location or hold an EU passport