Quality Assurance Officer

ASPHALION; Madrid; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Join a leading company in the pharmaceutical industry as a QA professional. You will be responsible for maintaining ISO certifications, conducting audits, and promoting a QA culture. Enjoy a flexible working schedule and a supportive environment for personal development.

Servicios

Flexible working schedule

Home office & Hybrid or Remote Model

Training and personal development program

English lessons

Well-being program

Formación

• Minimum 2 years of experience in QA.
• Experience in the pharmaceutical industry is preferred.

Responsabilidades

• Maintain ISO certifications and ensure compliance.
• Plan and conduct internal audits.
• Manage non-conformities and complaints.

Conocimientos

Communication

Organizational

Critical Thinking

Digitalization

Educación

Degree in Sciences

Herramientas

ISO 9001

ISO 13485

ISO 27001

Descripción del empleo

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 :

1. Maintain ISO certifications, ensuring compliance with internal, legal / regulatory standards and client requirements.
2. Monitor and review internal processes, including tracking of KPIs.
3. Support risk and opportunities management activities.
4. Plan and conduct internal audits.
5. Coordinate and support external audits (clients / regulatory bodies).
6. Participate in the qualification and approval of service providers, including conducting audits.
7. Manage non-conformities and complaints.
8. Oversee and manage CAPA processes, including the definition and tracking of actions, the implementation of solutions, and the documentation of evidence.
9. Provide QA guidance across departments.
10. Promote QA culture within the company, assisting in the development of plans to achieve this.
11. Assist in the digitalization of the QA department.
12. Oversee document control, including updates to SOPs / WIs, the implementation of new procedures, and the management of associated training.

Requirements :

1. Degree in Sciences (Pharmacy, Biology, Chemistry or similar). Minimum
2. 2 years of experience in QA
3. Experience in the pharmaceutical industry is preferred.
4. Strong knowledge of ISO 9001 standards, with familiarity in ISO 13485 and ISO 27001 being an asset.
5. Experience or knowledge in areas such as Regulatory Affairs, Pharmacovigilance, or Medical Devices is nice to have.
6. Fluent in English (C1) and Spanish (written and spoken).
7. Proactive, with strong communication, organizational, and client interaction skills, as well as some digitalization skills and critical thinking abilities.

Why work at Asphalion?

• 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 Passion, Flexibility, Commitment, Quality & Companionship.
• 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.