Menarini Ricerche S.p.A., PK-DM Department – Pomezia – Corporate Clinical Pharmacology & Pharmacometrics, started a computerization program for its laboratories and the implementation of a LIMS (Laboratory Informatic Management System) is a leading part in this project. The new position will operate in the PKDM department reporting to GxP Manager
MAIN ACTIVITIES AND RESPONSIBILITIES
- Participate 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)
- Planning, conducting and reporting CS Validation Processes
- Perform testing activities.
- Attend individual as well as collective training by e.g. evaluating state of the art of registration agencies papers, attending to trainings and workshops, etc.
- Manage configuration changes and periodic reviews of the system.
- Take part to the Projects Team and support senior colleagues to implement the system in compliance with internal procedures and regulatory requirements.
- Education: Bachelor Degree in Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry or related matters
- Years of experience: 1-3 in Pharmaceutical Industry related to Informatics infrastructure management and Computer System management
QUALIFICATION AND SKILLS
- Experience in CSV activity related to software managing analytical systems (i.e. Analyst, Empower).
- Knowledge of the processes that regulates Bioanalytical Laboratories.
- Knowledge of CFR 21 Parte 11 and EU/GMP Annex 11 rules, ISPE GAMP5 guidelines, and Data Integrity guidelines (i.e. MHRA, WHO, EMA, FDA).
- Knowledge and experience on commercial LIMS (i.e. Thermo Scientific Sample Manager LIMS, LabWare LIMS, STARLIMS, SoftLab, WATSON, NuGenesis) is considered a plus
- Ability to plan activities and manage CSV regulatory documents delivering within expected timelines. In this environment, the candidate should have a good knowledge of CSV, DI, GLP, GCP procedures.
- Fluent English both oral and written
CONTRACT DURATION: 12 months