Quality Assurance Gmp Assistant

14 ore fa

Milano, Italia Fondazione Telethon A tempo pieno

Fondazione Telethon ETS is committed to developing therapeutic options for patients affected by rare genetic disorders.
Fondazione Telethon pipeline consists in various programs at different development stages (from pre-clinical to commercial).
For such programs, Fondazione Telethon is responsible, among others, for the production and distribution of Advanced Therapy Medicinal Products.
The primary objective of this position is to support the QA Unit in the maintenance, management and development of Fondazione Telethon Quality Management System, with particular relevance to aspects related to GMP Quality Assurance.
The Quality Assurance Assistant will interact closely with the other QA functions, the CMC Unit, the Regulatory Affairs Unit, the Supply Chain Unit and with external vendors.RESPONSABILITIES:Support the QA unit in the quality oversight of external GMP vendors, with particular relevance to: suppliers qualification; handling of external quality events; handling of external change controls;
Support the QA unit in the management of internal change controls and non-compliances, including root cause investigations, to evaluate and resolve quality issues and to enhance continuous improvement;
Support the Supply Chain function in guaranteeing that subcontracted storage and distribution activities are conducted following GDP principles and product-specific requirements;
Support the QA unit in the maintenance and improvement of the existing Quality Management System through writing/revision of SOPs;
Support the QA unit in personnel training to GMP-related documents and tasks;
Assist the QA unit in the preparation and conduction of regulatory inspections and self-inspections.QUALIFICATIONS:Degree in a relevant scientific discipline;
1-2 years of previous experience in Quality Assurance, preferably GMP;
Previous experience with ATMPs, with sterile productions and/or with GDP is a plus;
Excellent English oral and written communication;
Ability to work autonomously and prioritize workflow;
Demonstrated analytical, problem resolution and communication skills.ADDITIONAL INFORMATION:
The position in based on Milan;
Hybrid working.

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