Quality Asurance Senior Specialist - Pharma/Biotech

San Sebastián Permanente

Actualizado el 22/02/2024

  • Strong CDMO in San Sebastian surroundings
  • QA Operations

¿Dónde vas a trabajar?

Strong CDMO company with high-performance project and facilities near San Sebastian.

¿Qué harás en tu nuevo puesto?

The holder of this position, reporting to Quality Assurance Director, is a key member of the local management team and plays a major role in the overall management of the site and will lead the Quality Assurance Operations department. In this context he/she is mainly responsible for:

  • Continuous improvement of Key Quality Indicators of company
  • Lead inspections from regulatory agencies and customer related audits.
  • Contact point for GxP departments for deviations, change control and CAPA management derived from production.
  • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
  • Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.
  • Participate actively in the digitalization roadmap of company
  • Develops and implements quality standard operating procedures.
  • Collaborate in daily activities of department such as, deviation and change management.
  • Interact with regulatory agencies during inspections.
  • Collaborates with customers during product lifecycle.

¿A quién buscamos (H/M/D)?

  • Bachelor's degree in Biochemistry, Biology, Chemistry, Pharmacy or related industrial, scientific, or business field required.
  • > 5 years of related experience in pharma industry, leading quality teams in manufacturing environments.
  • Fluent in English is a must.
  • Availability to work in a daily basis in San Sebastian area
  • Knowledge on biological process is a plus.
  • Knowledge on aseptic drug product manufacturing is a plus.
  • Excellent verbal and written communication, team leadership and problem-solving skills.
  • Excellent organizational skills and attention to detail.
  • Very high social competence with persuasiveness and self-confidence, high level of energy and positivity based on a sincere personality.
  • Team Player with a strong drive to create positive work environment, able to motivate and empower employees.

¿Cuáles son tus beneficios?

Oportunidades de carrera y desarrollo profesional.

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Cayetano Nogueras
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Resumen de empleo

Sub Sector
Healthcare / Pharmaceutical
San Sebastián
Tipo de Contracto
Nombre del consultor
Cayetano Nogueras
Número de referencia

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