QA Operations Technician

Ubicación: San Sebastián (España)
Tipo de Contrato: Indefinido
Jornada laboral: Jornada completa
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 Operations team. In this role, you will be responsible for ensuring compliance with GMP and ensure that our manufacturing process 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:

Implement and effectively maintain the quality management system.
Ensure compliance with applicable GMP regulatory standards and guidelines.
Revision of manufacturing batch records and quality control records of GMP batches required for product certification/confirmation
Manage the document control system ensuring the accuracy completeness and accessibility of quality related documents.
Assist in the review, preparation and maintenance of all quality-related documents, including protocols, reports, SOPs, batch records, specifications…
Identify issues found during the review of batch documentation.
Management of complaints, quality events and change control.
Collaborate with internal teams to implement CAPAs resulting from audits, inspections, and quality assessments.
Track and monitor the effectiveness of CAPAs.
Attend the technical teams in the daily event of quality with the support of Quality Assurance team.
Assist in the development and implementation of training programs related to GMP.
Participate in the continuous improvement.
Ensure the effective communication and escalation process of quality issues to appropriate management levels.
Provide support in project activities
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.
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)
Tipo de Contrato: Indefinido
Jornada laboral: Jornada completa
Sector: Farmacéutico y biotecnología
Vacantes: 1
Disciplina: Calidad
Modalidad de trabajo: Presencial

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