Sterility Assurance Consultant

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 Sterility Assurance Consultant

The Candidate will be placed in the Quality Assurance/Quality Control department and in the Sterility Assurance role will have to guarantee the robustness of the sterile drug production processes in compliance with company procedures and regulations in force.

The work place is Aprilia (LT)

YOUR ROLE:

Supervises daily production activities to ensure the correct application of the CCS (contamination control strategy)

Collaborates in the implementation of all validations relating to aseptic processes APS (Aseptic process simulation/media fill) sterilizing filtrations sanitizing agents sterilization and depyrogenation processes.

Writes procedures for production in controlled contamination environments.

Participates in staff training and their qualification in a classified environment.

Performs environmental and personnel monitoring and evaluates trends.

Performs investigations in collaboration with other company functions (Production; QC; QA Maintenance) in case of noncompliance.

Evaluates all impacts on aseptic processes

YOUR PROFILE:

Specialist degree in Pharmacy CTF Biology Chemistry or similar;

At least 2 years of professional experience gained in the pharmaceutical field in QA or micro QC departments in sterile drug production companies.

Knowledge of aseptic processes sterility and notions of pharmaceutical microbiology;

Knowledge of cGMP and regulatory requirements in this area (annex 1)

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 within the national territory is also required.