QC Tech Transfer, Qualification & Validation Specialist

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

As a QC Specialist you will be responsible for ensuring that our processes and products comply with applicable quality standards and regulations. You will be a key player in the management of analytical method development and validations, as well as collaborating with cross-functional teams to optimize our analytical methods. Your experience in method validation will be critical to drive continuous improvement and ensure operational excellence.

Key Tasks:

Contribute to the development of new methodologies and improvements in validation processes.
Collaborate with cross-functional teams to optimize analytical methods and resolve technical issues.
Write and review validation protocols for analytical methods.
Perform data analysis and evaluation to ensure compliance with guidelines.
Maintain accurate records of validation activities and ensure proper documentation.
Train other team members in validation practices and regulatory compliance.

Key Working Relation:

Reports functionally to QC TT, Qualification & Validation Expert.
Quality departments.
Project Management and Bussiness Development.
Operations (Manufacturing, R&D, MSAT).

Requisitos

Skills & Qualifications:

Degree in Biological Sciences, Engineering or related field.
Deep knowledge of analytical methods in one or more of the following areas: molecular biology (qPCR, dPCR, sequencing), biochemistry (ELISA, CE-SDS), physicochemistry (HPLC).
Minimum of 3 years of laboratory experience developing and executing analytical assays.
At least 1 year experience working in GMP environment and in analytical method validation.
Knowledge of applicable quality standards and regulations.
Proficient in both written and spoken English.
Exceptional attention to detail, reliability and ability to work in a regulated environment.
Excellent problem solving and analytical skills, with a data-driven approach to decision making.
Strong communication and interpersonal skills, with the ability to collaborate effectively across functions.
Company Values: Humility, Empathy, Responsibility, Commitment, Teamwork and Effort.

We Offer:

Stable contract with a 4-month trial period.
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, flexible working hours, possibility to work remotely (hybrid), etc.

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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