Quality Assurance Manager
Santhera Pharmaceuticals (Schweiz) AG
Date de publication :
22 mars 2025Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Pratteln
Résumé de l'emploi
Santhera Pharmaceuticals est une entreprise suisse spécialisée dans les médicaments.
Tâches
- Maintenir et améliorer le système de gestion de la qualité GMP/GDP.
- Assurer que la fabrication et les tests respectent les exigences cGMP.
- Conduire des audits GMP/GDP internes et externes.
Compétences
- Diplôme en pharmacie, chimie, ingénierie ou sciences de la vie.
- Compétences analytiques et de résolution de problèmes.
- Capacité à travailler de manière autonome et à gérer plusieurs projets.
Est-ce utile ?
Senior Manager GMP QA
Location: Pratteln, Switzerland (Hybrid) Scope of Work
We are looking for a Senior Manager GMP QA to maintain and enhance Santhera's GMP compliance and Quality Assurance strategies. Reporting to the Head of Quality Management, this role oversees GMP/GDP quality projects for development and commercial-stage products. The position collaborates with internal teams, including Technical Development & Operations (TDO), Supply Chain, and Regulatory Affairs, as well as external partners, contractors, and Health Authorities.
This role ensures products (DS and DP) meet global GMP/GDP standards, internal policies, and regulatory requirements. The job holder will be responsible for maintaining the GMP/GDP Quality Management System (QMS), conducting audits, managing compliance activities, and supporting regulatory inspections. Key Responsibilities
- Maintain and improve GMP/GDP QMS in compliance with company policies and global regulations.
- Ensure manufacturing, testing, and distribution meet cGMP requirements.
- Conduct and oversee internal and external GMP/GDP audits.
- Manage GMP/GDP SOPs and ensure regulatory alignment.
- Oversee batch record review and product release.
- Monitor and manage supplier qualifications, audits, and performance evaluations.
- Support investigations, deviations, change controls, and CAPA implementation.
- Ensure regulatory compliance by tracking industry updates and implementing necessary changes.
- Maintain the Site Master File and ensure readiness for Health Authority inspections.
- Support Quality Council meetings, KPIs monitoring, and product defect assessments.
- Bachelor's or advanced degree in pharmacy, chemistry, engineering, or life sciences.
- 7+ years of experience in the pharmaceutical/biotech industry.
- 5+ years in GMP Quality Assurance at a local or global level.
- Strong knowledge of cGMP global regulatory requirements and quality systems.
- Fluency in English (additional languages are a plus).
- Strong problem-solving and analytical skills.
- Excellent planning, organizing, and time management abilities.
- Ability to work independently and manage multiple projects in a fast-paced environment.
- Reliable team player with leadership skills in cross-functional settings.
- Solution-oriented, proactive, and adaptable in dynamic situations.
