04 ott - Saluggia
Azienda importante
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
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