QA Compliance Specialist – Quality Assurance

About the role

ONE PHARMA S.A. is looking for a QA Compliance Specialist to join its Quality Assurance team at the production plant in Schimatari, Greece. The role will support product quality and regulatory compliance through documentation management, batch record review, dossier maintenance and audit activities.

Key responsibilities

• Maintain up‑to‑date product dossiers and support applications for new product licences, formulations and market introductions.
• Ensure compliance with GMP, GDP and other regulatory requirements, manage changes affecting dossiers, including CEP updates and analytical method validations.
• Review analytical methods and QC practices against registered dossiers and identify discrepancies.
• Prepare risk assessments for nitrosamines and other quality‑related projects.
• Support internal, customer and regulatory audits, prepare responses to findings and follow up on corrective actions.
• Deliver induction and refresher training on assigned procedures.
• Collaborate with QA Systems and QA Operations to harmonise quality policies, manuals and procedures.
• Contribute to analytical method validation protocols, manufacturing instructions for feasibility and NPI batches, and quality technical agreements.
• Track and resolve CAPAs and manage change controls related to new products or regulatory updates.

Required profile

• Experience in pharmaceutical quality assurance or regulatory compliance.
• Familiarity with GMP, GDP and product dossier management.
• Ability to work cross‑functionally with QA, QC, production, customers and suppliers.
• Strong analytical and documentation skills.

Required skills

• GMP and GDP knowledge
• Analytical method validation
• Risk assessment (e.g., nitrosamines)
• CAPA management
• Change control procedures
• Audit preparation and support
• Quality systems documentation
• Product dossier maintenance