Commercial Quality Specialist
4 semanas atrás
**Commercial Quality Specialist**-2307006749W
Description
The Commercial Quality (CQ) Specialist is responsible for implementation and maintenance of the appropriate Quality Standards and Systems for the operation of the Portuguese Consumer Health organization. It will also be responsible for partnering with the Portugal Business Head and Management in quality questions & issues and liaison with multiple Quality organizations to drive timely resolution of Quality related issues.
This position is based in Portugal and reports to CQ Iberian Head. It will also support the Southern European Cluster team in defining and implementing departmental strategies and services to optimize and harmonize processes and find opportunities to collaborate in the Cluster and Region
The CQ Specialist Portugal will act as a back-up to the Technical Director role, acting as Responsible Person backup for medicines and technical responsible for cosmetics distributed by Johnson & Johnson Portugal and point of contact backup with Health Authorities.
**Key Responsibilities**:
- Consumer Quality Management System (QMS) & continuous improvement: Ensure that all local or Cluster Standard Operating Procedures (SOPs) that describe all GxP related processes are established ensuring adequacy and continuous improvement
- New Product Introduction (NPI) & Product Lifecycle: quality approval of all products marketed in the local markets
- Training: Local monitoring and oversight of quality related Training
- Change Controls: ensure that any changes affecting the distribution related activities are appropriately controlled and supervised.
- Document & Data Management: ensure that a document and data management system is accurately implemented according to internal and local regulatory requirements
- Non-Conformances (NC) & Corrective/ Preventive Actions (CAPA): processing of NCs, Root Cause Analysis and CAPAs and on time closure.
- CQ Community: Participation in workshops and projects, task forces at SE&F Cluster and EMEA Regional level on Quality related topics.
**Qualifications**:
**Education**:
- University Scientific degree, preferably in Pharmaceutical Sciences
**Experience and Skills**:
**Required**:
- Fluency in English
- At least 2-4 years of work experience, in Quality Assurance in pharmaceutical and/or cosmetic
- Up-to-date knowledge of relevant pharmaceutical legislation and GxP regulations
- Knowledge and full understanding of the J&J Quality System Policy
**Preferred**:
- Intermediate in Spanish
Primary Location Europe/Middle East/Africa-Portugal-Lisbon-Lisbon
Organization JNTL Consumer Health (Portugal) Limitada
Job Function Quality (Generalist)
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