menu
menu
Carreiras
Faça parte da nossa equipa e evolua connosco.
Sofarimex
System Validation Specialist – Computerized Systems (m/f)
23 abril, 2025
We are currently recruiting a System Validation Specialist – Computerized Systems for Sofarimex, our pharmaceutical production unit in Cacém.
Responsibilities:
- Establish, revise, and maintain validation plans and procedures for equipment qualification to ensure cGMP compliance;
- Develop and execute validation protocols and generate reports for computer systems;
- Conduct risk assessments and gap analyses to identify areas of non-compliance;
- Collaborate with stakeholders to define validation requirements and implement solutions;
- Perform qualification tests, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ);
- Manage projects related to computerized equipment and computer system validation (CSV) and perform data integrity assessments;
- Document validation activities and maintain validation documentation throughout the system lifecycle;
- Provide support during regulatory inspections and audits;
- Stay up-to-date on industry best practices and regulatory updates related to CSV.
Qualifications and Skills:
- Degree in Computer Science, Engineering, or related field;
- Experience in computer system validation;
- Knowledge of GMP guidelines, and industry standards;
- Experience with validation tools and methodologies;
- Empower 3 knowledge (preferential);
- Good analytical and problem-solving skills;
- Good communication and teamwork abilities;
- Attention to detail and the ability to work independently.