Recipharm is hiring a Computerized Systems Validation (CSV) Specialist!
Recipharm is a leading pharmaceutical company with over 75 years of experience providing integrated services, from drug development to manufacturing, always ensuring high standards of quality, safety, and regulatory compliance.
If you are interested in computerized systems within a GMP environment and are looking for a new challenge in a solid and growing company, this could be the right opportunity for you.
To join our Engineering Department, within the Qualification and CSV team, we are looking for a Computerized Systems Validation Specialist with the following mission:
- Define the strategy and coordinate Computerized Systems Validation (CSV) activities, ensuring compliance with applicable regulatory requirements;
• Plan and manage the annual CSV activity plan;
• Contribute to the Data Integrity strategy, including preparation and review of related documentation;
• Define and ensure the execution of system validation processes, including preparation and review of documentation (protocols, reports, etc.), ensuring systems remain in a validated state;
• Manage the validation lifecycle of systems, promoting continuous improvement;
• Coordinate the introduction of new systems, including requirements definition;
• Manage and oversee external partners involved in validation activities;
• Participate in projects related to computerized systems;
• Support client audits and regulatory inspections as a CSV subject matter expert;
• Assess deviations related to computerized systems and data integrity;
• Evaluate and follow up on change controls related to systems.
Profile
- Bachelor’s degree in Science, Engineering, Computer Science, or a related field;
• 2 to 3 years of experience in the pharmaceutical industry, preferably in CSV, system testing, and/or data integrity;
• Solid knowledge of GMP;
• Good IT skills and fluency in English;
• Strong organizational skills, critical thinking, and attention to detail;
• Good communication skills and ability to work in a team;
• Proactive, dynamic, and responsible.
What we offer
- Integration into a solid and growing international company;
• Integration into a specialized technical team focused on innovation and continuous improvement;
• Salary package aligned with the role and experience.
Location: Lisbon || Work schedule: Full-time
If you are looking for a technical challenge in a critical area for the quality and safety of medicines, we encourage you to apply.