CSV
SPECIALIST

The role of the Computer System Validation Specialist will involve managing and coordinating Qualification activities specifically:

Responsibilities:

• Manage and coordinate Qualification activities (IQ/OQ) for standalone computerized systems;


• Issue System Configuration documents for standalone/networked computerized systems;


• Draft, review, and execute qualification protocols and tests (FAT, SAT, IQ, OQ, PQ);


• Develop validation plans for computerized systems;


• Perform Risk Analysis (Risk Assessment and Process Mapping);


• Draft and prepare Standard Operating Procedures (SOPs).

Requirements:

To fill this role, the candidate must meet the following requirements:

• Bachelor’s or Master’s degree in technical-engineering fields;


• Previous experience in a similar role;


• Excellent knowledge of the English language;


• Proficiency in Microsoft Office suite;


• Willingness to travel frequently.

Additional Skills:

• Multitasking abilities, analytical skills, and a strong sense of initiative;


• Precision and attention to detail;


• Problem-solving and analytical skills;


• Strong communication skills and a team-oriented mindset;


• Availability for frequent domestic and international travel;


• Good command of the English language.

We offer: An engaging growth path with the leading clients in the pharmaceutical sector, providing opportunities for professional development in a dynamic and innovative environment.

The compensation package will be commensurate with the candidate’s experience.