Analytical QC & AS&T Expert

Job Description Summary

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