Quality Asurance Senior Specialist - Pharma/Biotech
Location
Guipúzcoa | Spain
Job description
de la oferta
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.
Perfil del candidato
- 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.
Oferta de empleo
Oportunidades de carrera y desarrollo profesional.
Número de vacantes: 1
Modalidad de trabajo: Presencial
Tipo de contrato: Full-Time
Remuneración anual: Negotiable
Job tags
Salary
