Analytical QC & AS&T Expert

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

#J-18808-Ljbffr