THE COMPANY

Pharmaceutical Multinational Company

LIMS Specialist

THE ROLE

• Partecipate to the LIMS system configuration (design, roles, connected instruments, operative procedures, training) and validation;
• Issue and review of validation documents (URS, VPL, RAR, Testing Protocols);
• Perform testing activities;
• Manage configuration changes and periodic reviews of the system;
• Take part to the Projects Team and support colleagues to implement the system in compliance with internal procedures and regulatory requirements.

PERSONAL ATTRIBUTES

• Degree in Chemical and Pharmaceutical Technologies or similar;
• 3 / 4 years of experience in the role in Pharmaceutical Sector;
• Experience in CSV activity;
• Knowledge of the processes which regulates Bioanalytical Laboratories;
• Knowledge of CFR 21 part 11 and EU/GMP annex 11 rules, ISPE GAMP5 guidelines and data integrity guidelines (MHRA, WHO, EMA, FDA);
• Knowledge and experience on LIMS (Thermo Scientific Sample Manager LIMS, Labware LIMS, STARLIMS, SOFTLABS, WATSON, NuGenesis) will be considered a plus;
• Good knowledge of English.

LOCATION: Rome