Qualification Specialist - AYES - Management & Technology Consulting

26 ott - Lazio
AYES - Management u0026 Technology Consulting

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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