Qa Specialist - Iii (Senior) - 24004

Descripción del Empleo:
Manages, evaluates and approves changes assuring they are in compliance with applicable SOP’s, quality manual, products market filing, and qualification (as applicable) and are closed with all the supporting documentation. Ensures the update of all impacted documentation prior to the implementation of the change.
Requisitos:
1. Bachelor's or master’s Degree in Science or Engineering with at least eight (8) years of experience in the pharmaceutical industry within the Quality Operations Department.
2. Knowledgeable with cGMP's applied to drug product and manufacturing is required.
3. Technical knowledge in manufacturing/packaging processes and testing techniques.
4. Effective planning skills.
5. Excellent interpersonal and communication (oral and written) skills, in English and Spanish.
6. Skills: Technical Writing, Qualifications/Validation.
7. Experience with MIDAS and Trackwise preferable resolutions when required and participating in global QMS documentation development.