GMP Sterility Assurance Specialist

Role Overview Philogen S.p.A. is looking for a "GMP Sterility Assurance Specialist/Expert" who will report to the GMP Quality Assurance Manager and contribute to the definition, implementation, and verification of Contamination Control strategies, ensuring compliance with applicable GMP regulations and company standards.

Responsibilities Supporting sterility assurance and contamination control activities by contributing to the development and maintenance of the company Contamination Control Strategy;

Supporting microbiological risk assessments related to processes, environments, materials, personnel, and equipment;

Collaborating in the management and review of Environmental Monitoring, Personnel Monitoring, and microbiological trend analyses;

Supporting the qualification and maintenance of the state of control of clean rooms, isolators, RABS, HVAC systems, and critical utilities;

Writing, reviewing and approving GMP documentation including SOPs, protocols, reports, risk assessments, deviations, CAPA, and change controls;

Contributing to investigations related to sterility assurance and contamination control;

Reviewing production and quality batch records related to Aseptic Process Simulation activities;

Identifying and recommending continuous improvement initiatives related to aseptic practices, cleaning, disinfection, and contamination prevention;

Implementing action plans and supporting the development of quality strategies, priorities, and short- and long-term objectives;

Writing and reviewing CCS risk assessments;

Participating in internal audits, customer audits, and regulatory inspections on topics related to sterility assurance;

Collaborating with Production, QC Microbiology, QA, Engineering and Validation to ensure the control of sterile processes.

Qualifications

A strong scientific background (ideally in Biology, Biotechnology, etc.);

Previous experience in Sterility Assurance (at least three years);

Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development and manufacturing;

A good level of English language, both written and spoken;

A high level of attention to detail and with the ability to prioritize working tasks;

A strong flexibility in changing tasks and priorities;

The ability to work independently as well as coordinate members of his/her team;

Excellent interpersonal skills and ability to work in teams.

Benefits

A contract and salary proportional to the experience of the successful candidate.

Location

Siena

EEO Statement We welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.
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