We are looking for a Quality Assurance & CSV Officer with experience in the pharmaceutical industry to join our team.
If you enjoy taking on new challenges, working in an international environment, and want to grow with us—this might be your next career move

Main responsibilities:

• Maintain ISO certifications, ensuring compliance with internal, legal/regulatory standards and client requirements.
• Monitor and review internal processes, including tracking of KPIs.
• Support risk and opportunities management activities.
• Plan and conduct internal audits.
• Coordinate and support external audits (clients/regulatory bodies).
• Participate in the qualification and approval of service providers, including conducting audits.
• Manage non-conformities and complaints.
• Oversee and manage CAPA processes, including the definition and tracking of actions, the implementation of solutions and the documentation of evidence.
• Provide QA guidance across departments.
• Promote QA culture within the company, assisting in the development of plans to achieve this.




• Assist in the digitalization of the QA department.
• Oversee document control, including updates to SOPs/WIs, the implementation of new procedures and the management of associated training.
• Coordinate CSV activities for computerized systems in accordance with applicable GxP requirements and internal procedures.
• Prepare and review technical documentation, including traceability matrices and the validation documentation package.
• Ensure computerized systems are maintained in a validated state throughout their lifecycle, including change control, periodic review, deviations and CAPAs.

Requirements:
• Degree in Sciences (Pharmacy, Biology, Chemistry or similar).
• Minimum 2 years of experience in QA or related role, experience in the pharmaceutical industry is preferred.
• Strong knowledge of ISO 9001 standards, with familiarity in ISO 13485 and ISO 27001 being an asset.
• Experience in computerized systems validatio

📌 Quality Assurance (Barcelona)
🏢 Asphalion
📍 Barcelona