Analytical QC & AS&T Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hgwp8

Job Description Summary

The Analytical QC & AS&T; Expert is in charge of method lifecycle, laboratory performance and compliance.

Job Description

Major Accountabilities:

- Manage and guarantee the fulfillment of AS&T;'s own tasks in the Laboratory.

- Responsible for the development / validation / verification / transfer / troubleshooting / monitoring of analytical methods

- Evaluate the implementation of new technologies and new equipment and lead the qualification according to Novartis and regulatory standards

- Plan the analyses of the QC & AS&T; department of the Laboratory based on the plans and needs of AS&T.;

- Guarantee the compliance with dossiers and relevant pharmacopoeia regarding the testing methods in place.

- Collaborate in the product submission to the Regulatory Authorities for the field of expertise.

- Manage the method lifecycle and periodically monitor the performance; propose solutions if needed.





- Guarantee the management of deviations, OOS, OOT, OOE and investigations as per internal SOPs.

- Cooperate with all the departments at the resolution of extra-laboratory investigations.

- Put in place corrective and preventive actions and guarantee the correct flow and timely closure.

Essential requirements:

- Scientific Degree (CTF, Pharmacy, Chemical Sciences).

- Previous solid experience in a Quality Control laboratory within the pharmaceutical/biotech industry.

- Experience with validation activities (analytical methods and/or lab equipment).

- Fluent in Italian and English.

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hgwp8