Quality Asurance Senior Specialist - Pharma/Biotech

• Strong CDMO in San Sebastian surroundings|QA Operations

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

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.

Oportunidades de carrera y desarrollo profesional.

• 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.