Qualification Specialist

Overview

AYES, multinational consultancy in engineering and technology, is expanding in Italy and abroad and is seeking a Qualification Specialist in the pharmaceutical field in Lazio.

AYES operates globally, offering advanced solutions and innovative projects in Automotive, Aerospace and Defense, Rail, Energy, Oil & Gas, Life Sciences and Telecommunications. With offices in Italy, Europe and the United States, we support clients with high-level engineering expertise, addressing complex challenges and promoting innovation in every area.

Responsibilities

• Draft, review and execute qualification protocols IQ, OQ, PQ for production plants and equipment.


• Support installation, testing and commissioning activities of equipment.


• Manage and maintain GMP documentation related to qualification activities.


• Collaborate with Production, Engineering, Maintenance and QA to ensure an integrated and compliant approach.


• Contribute to the optimization and standardization of qualification processes.


• Degree in scientific disciplines (CTF, Chemistry, Biotechnology, Engineering or related).


• Experience 1 to 3 years in qualification/validation activities in the pharmaceutical field.


• Strong knowledge of GMP, Annex 15, EMA/FDA guidelines.


• Experience in drafting and reviewing qualification protocols (IQ, OQ, PQ, URS).


• Organizational skills, attention to detail and problem solving.


• Good written and spoken English.