QA Technician

Ubicación: San Sebastián (España)
Sector: Farmacéutico y biotecnología
Vacantes: 1
Disciplina: Calidad
Modalidad de trabajo: Presencial

Viralgen Vector Core, S.L.U.

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world. We want to make gene therapy accessible to all who live with a genetic disease.

Descripción de la oferta

About the role

We are seeking a motivated QA Technician to join our Quality Assurance External & Compliance team. In this role, you will be responsible for ensuring compliance with GMP and ensure that all external services and suppliers meet the required quality standards and regulatory requirements. You will play a crucial role in maintaining compliance with industry regulations and ensuring that our products are safe and effective.

Key Tasks:

Audit preparation activities (auditor logistics, front room/backroom arrangements, identifying/preparing SME’s). Prepare responses to external audits, inspection or other regulatory notification.
Establish and execute an effective internal audit schedule.
Ensure adequate corrective actions for interna/external audit observations, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
Drive compliance and improvement in internal/external audit metrics
Suppliers’ qualifications for materials and outsourced activities. Documenting risk-based approach for supplier qualification, selection, qualification, approval, and maintenance of suppliers to ensure compliance with quality standards and regulatory requirements
Monitor and evaluate the performance of external services and suppliers, documenting any deviations, complaints and facilitating corrective actions as needed.
Collaborate with internal teams to address quality issues related to external services and ensure effective communication with suppliers.
Collaborate with external partners and clients to ensure compliance with quality agreements and regulatory requirements. Client notification of deviations, change control, OOS or others according to the quality agreements in force.
Review and approve quality documentation.
Participate in risk assessments and quality reviews to identify potential compliance issues and recommend improvements.
Support training initiatives for internal staff on GMP compliance and quality assurance practices.
Stay updated on industry regulations and best practices regarding for GMP compliance.

Requisitos

Skills & Qualifications:

Bachelor’s degree in a Science field (e.g., Pharmacy, Biology, Chemistry, Biotechnology).
Minimum of 2 years of experience in quality or production roles in Viralgen.
Knowledge of quality control methodologies and regulatory requirements.
Strong attention to detail and analytical skills.
Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.
Adaptability in using quality management software and tools.
Ability to work in a fast-paced environment and manage multiple tasks effectively.
Company values: Humility, Empathy, Responsibility, Commitment, Teamwork, and Effort.

We Offer:

A dynamic and collaborative work environment.
Opportunities for professional development and continuous training.
Direct impact on the development of therapies that improve people's lives.
Additional benefits; health insurance, vacation, flexibility, etc.

If you are ready to take your career to the next level and make a difference in the world of biotechnology, we would like to meet you!

Ubicación: San Sebastián (España)
Sector: Farmacéutico y biotecnología
Vacantes: 1
Disciplina: Calidad
Modalidad de trabajo: Presencial

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