QC Supervision Technician (Biology Laboratory)

3PBIOVIAN; Noáin; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

3PBiovian, une entreprise biopharmaceutique en pleine croissance, recherche un professionnel pour son département de contrôle qualité biologique. Le candidat idéal aura une formation en pharmacie ou discipline connexe, avec une expérience significative dans les méthodes analytiques. Ce poste offre une opportunité de carrière stable avec des avantages compétitifs et un environnement de travail international.

Servicios

39 jours de congés payés

Plan de compensation flexible

Assistance à la relocalisation

Formación

• Diplôme en pharmacie ou domaine connexe requis.
• Au moins 4 ans d'expérience avec des méthodes analytiques.
• Connaissance des directives réglementaires pharmaceutiques.

Responsabilidades

• Assurer les activités GMP dans le laboratoire biologique.
• Évaluer et réviser la documentation technique liée au contrôle qualité.
• Former et qualifier les analystes pour effectuer les contrôles correctement.

Conocimientos

SDS-PAGE

Western-Blot

ELISA

qPCR

Contrôle de l'eau pour injection

Educación

Bac +5 en Pharmacie, Génie Chimique, Biochimie ou disciplines connexes

Descripción del empleo

¿Are you looking for an opportunity to develop your professional career in a CDMO Quality Control department?

From day one, 3PBiovian has been inspired by the people that form it. One of the company's main values is the professional and personal growth of its employees in an international and biotechnological environment.

Currently, the Navarra site of 3PBiovian is seeking professionals who want to focus their careers in the Biological Quality Control department.

The successful candidate will join 3PBiovian in Navarra, Spain, as part of our Quality Control team.

The candidate will be responsible for:

• Ensuring GMP activities in the biological laboratory.
• Evaluating and reviewing technical documentation related to Quality Control, including analytical results in routine manufacturing, validation, and transfer activities.
• Organizing and ensuring compliance with the weekly program, coordinating human, material, and technical resources.
• Proposing process improvements to enhance quality, cost-efficiency, performance, safety, and environmental impact.
• Training and qualifying analysts to carry out controls correctly.
• Maintaining laboratory installations in optimal condition, ensuring operation according to manufacturer manuals.
• Drafting and supervising SOPs and managing deviations in the laboratory.
• Coordinating the release of raw materials and analysis of intermediates, drug substances, and drug products.
• Supporting stability studies in collaboration with other technicians.
• Providing quality support during production incidents.
• Approving and closing CAPAs arising from deviations and efficacy verifications.
• Ensuring traceability of materials used in analyses.
• Performing additional duties as assigned and for which training has been received.

Assessment criteria:

• Bachelor’s degree in Pharmacy, Chemical Engineering, Biochemistry, or related disciplines.
• Fluency in English is valued.
• At least 4 years of experience with analytical methods such as SDS-PAGE, Western-Blot, protein concentration determination, ELISA, qPCR, water control for injection, etc.
• Experience with recombinant proteins, mAbs, Biosimilars, ADCs.
• Knowledge of pharmaceutical regulatory guidelines.

We offer:

• A permanent, stable position in a growing company.
• A competitive vacation package with 39 paid days off and an additional day off on December 26th.
• A flexible compensation plan allowing up to 30% of gross salary to be allocated to exempt services (childcare, health insurance, training, etc.).
• Access to our benefits club with discounts on various products and services (Booking, FNAC, Rituals, El Corte Inglés, etc.).
• Relocation assistance for new hires residing outside Navarra.
• And much more!

Interested in learning more about us?

It´s within us.