01 set - Roma
Altro
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.
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