Quality Trainee
hace 3 días
Reports to:
Quality Manager SWE
Location:
Sant Cugat del Valles
Employment Type:
Full-time /Part-time
Job Summary
The trainee will provide quality control services for the Spanish, Portuguese and Italian markets
Key Responsibilities
- Ensure and document compliance with GMP/GDP standards for pharmaceutical products, ISO 13485 for medical devices, ISO 22716, ISO 22000, and the applicable Directives/Regulations related to Uriach CHC products.
- Draft and update SOPs (Standard Operating Procedures) for the Quality Department.
- Write specifications in SAP QM according to regulatory registration or technical data sheets.
- Perform, monitor, and execute the analysis of all products in accordance with the applicable regulatory standards.
- Open non-conformities when appropriate and implement the corresponding corrective actions.
- Inform the CMO of any non-conformity.
- Participate in the execution and monitoring of the non-conformity indicator.
- Ensure the availability of samples from all batches, their custody, and proper storage conditions in the sample archive.
- Participate in the feasibility and development phase of products, establishing pre-stability requirements and evaluating them.
- Attend inspections, audits, and requests from health authorities.
- Collaborate in the monitoring of the general budget of the Department.
- Monitor and control the stability studies of all products.
- Manage the stability budget.
- Provide necessary information to the Supply, Innovation, or CHC ROW departments
.
Requirements
- Degree in pharmacy, chemistry, biology, food science and technology or similar.
- Fluent English.
- Fluent Italian is a plus
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