Sr. QARA Specialist (Complaints Management)-Pharma (Vallés Or)

Page Personnel; Barcelona; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A global pharmaceutical company in Barcelona is seeking a Senior QARA Specialist to manage quality system documentation and regulatory submissions. This role offers a permanent contract with a competitive salary, 60% telework, and numerous professional development opportunities. Ideal candidates will have strong investigative skills and regulatory knowledge.

Servicios

Competitive salary

3 days a week working from home

Flexible schedule

Ongoing training

Health insurance

Canteen

English training

Nursery check

Formación

• Experience in maintaining quality system documentation.
• Strong problem-solving skills for investigating quality issues.
• Ability to conduct audits and internal assessments.

Responsabilidades

• Collaborate in maintaining quality system documentation.
• Investigate and resolve quality issues.
• Support the regulatory submissions for market authorization.

Conocimientos

Quality system management

Investigative skills

Regulatory knowledge

Descripción del empleo

• Senior QARA Specialist (Complaints Management)
• Pharma (Vallés Or) / 60% Telework

Pharma Global Company with a software product.

• Collaborate in maintaining the quality system documentation processes and procedures adopted by the company.
• Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.
• Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.
• Support the regulatory submissions for market authorization for medical device products.
• Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures.
• Facilitate the approval process for software releases.
• Disseminating knowledge about the Quality System and regulatory requirements.
• Oversee post-market surveillance activities related to medical device products.
• Offer guidance and mentorship to QARA team members at lower levels.

• Permanent Contract.
• Competitive Salary.
• 3 days a week working from home.
• Flexible Schedule.
• Multicultural and friendly team.
• Exciting opportunities for professional development.
• Ongoing training.
• Multiple Social benefits: Canteen, health insurance, nursery check, English training...