Validation Specialist Consultant - Pharma

FORTIL is an engineering consulting company created by engineers with an entrepreneurial mentality. Our model born in 2009 is based not only on excellence and precision but also on constantly evolving sharing conditions. 100% of the groups shares belong to our employees who are guided towards share ownership in a path defined by levels of commitment and the contribution of added value for the group. Our intent is to increase the share of our associated employees to 30%.To date we have 2000 employees distributed in 13 countries what characterizes us is the interest in sustainability a high level of competence an agile organization and strong social action.Our goal: to become the largest independent engineering group in Europe serving future generations.By working with us you will come into contact with a young and ambitious team in a multicultural and international contextWe are looking for a Validation Specialist Consultant in the Pharma sector.

WHAT YOU WILL DO:The Candidate will be placed in the Quality Assurance department with the aim of guaranteeing the robustness and repeatability of the production processes.

Ensures that Process Validation and Cleaning Validation activities comply with regulatory requirements.

Analyzes the technical documentation necessary for the development of validation protocols.

Develops validation protocols and related reports

Develops statistical trends Develops Risk Assessment and Gap Analysis documents

Performs and supervises validation activities

Manages deviations/CAPA related to validation activities

Participates in staff training

YOUR PROFILE:

The ideal candidate possesses the following requirements:

Specialist degree in Pharmacy CTF Biology Chemistry or similar;

At least 1 year of professional experience gained in the pharmaceutical field preferably in contexts with the production of sterile drugs.

Knowledge of cGMP and the main regulations and guidelines.

Knowledge of Process and Cleaning validation principles (FDA; Eudralex; ICH)

Good knowledge of the English language.The profile is completed by personal characteristics of flexibility availability analytical and problem solving skills autonomy orientation towards achieving objectives aptitude for team work and excellent relational skills. Availability to travel nationally and internationally is also required.