QC Validation Specialist

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

Qualification / Validation Specialist
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? 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.
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. 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.),



Review master and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
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, Production, Quality Assurance, Maintenance, MSAT, and HSE functions within a CDMO environment.
Provide support during internal audits, client audits, and regulatory inspections (EMA, FDA), including periodic review of qualified systems.
Ensure the analysis and evaluation of raw technical data and documentation related to equipment and instruments subject to requalification, in order to acquire the information necessary for defining procedures/protocols and carrying out re-qualification activities

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