Qualification / Validation Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78ezwq

Qualification / Validation Specialist
for the site Borgo San Michele LT, Italy
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.
Your key responsibilities
We’re currently looking to expand our Quality and Engineering teams with experts in Qualification, as Qualification Specialist, Requalification Specialist and QA Equipment Validation Specialist. As we are recruiting for several roles, feel free to apply even if your profile does not match with all the requirements below.
PURPOSE AND RESPONSIBILITIES The purpose of these roles is to ensure the qualification status of the production equipment,



QC instrument & equipment and Warehouse through the definition of procedures/protocols and the execution of requalification activities, in compliance with applicable regulations (laws, GMP, FDA, etc.), the guidelines contained in the dossier, and company quality standards.
- Review master and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Troubleshoot / investigate validation-related deviations and non-conformances.
- Maintain organization and archival of completed validation and qualification document packages.
- Prepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations.
- Interface and coordinate qualification activities with Engineering, Producti

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78ezwq