Qualification Specialist

AYES - Management & Technology Consulting; Lazio; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading consultancy firm in Lazio is seeking a Qualification Specialist in the pharmaceutical field. This role involves drafting and executing qualification protocols, managing GMP documentation, and collaborating with various departments to ensure compliance. Candidates should have a degree in scientific disciplines and 1-3 years of experience in qualification activities, along with strong knowledge of GMP guidelines.

Competenze

• 1 to 3 years experience in qualification/validation activities in the pharmaceutical field.
• Experience in drafting and reviewing qualification protocols (IQ, OQ, PQ, URS).

Mansioni

• 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 compliance.
• Contribute to the optimization and standardization of qualification processes.

Conoscenze

Knowledge of GMP

Analytical skills

Problem solving

Attention to detail

Strong written and spoken English

Formazione

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

Descrizione del lavoro

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.