Quality Assurance & CSV Officer

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!

• 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.

• 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 validation (CSV) within a GxP-regulated environment being an asset.
• Experience or knowledge in areas such as Regulatory Affairs, Pharmacovigilance, or Medical Devices is nice to have.
• Fluent in English (C1) and Spanish (written and spoken).
• Affinity for and basic knowledge of AI, digitalization, and emerging technologies.
• Proactive, with strong communication, organizational, and client interaction skills, as well as critical thinking abilities.

Permanent contract.

Flexible working schedule - Friday until 15.30h.

Home office & Hybrid or Remote Model (You can be located anywhere in Spain!).

Wide variety of projects, new challenges and experiences.

Training and personal development program.

English lessons.

A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Commitment, Quality, Teamwork, Adaptability, Innovation & Purpose-led.

A highly & dynamic working environment with employees from more than 15 nationalities.

Our people and their well-being are our priority:
Physical, psychological and emotional well-being program.

Internal activities & RSC Activities.

Equal Opportunity Employer.