Qa Specialist Iii

Descripción del Empleo:
SUMMARY • Works with the site validation teams providing guidance in the strategy, planning, delivery and retirement of computerized systems, equipment, facilities and utilities qualification, among other systems. Reviews and approves cGMP documents associated to the project in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals. Ensures quality concerns and/or opportunities are presented to management and/or project teams for prompt resolution .
• Manages, evaluates and approves changes assuring they follow 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:
TECHNICAL COMPETENCIES: •Knowledgeable with cGMP's applied to drug product and manufacturing is required.
•Technical knowledge in manufacturing/packaging processes and testing techniques.
•Effective planning skills.
•Excellent interpersonal and communication (oral and written) skills, in English and Spanish.
•Skills: Technical Writing, Qualifications/Validation.
•Experience with MIDAS and Trackwise preferable.
EDUCATION / EXPERIENCE
•Bachelor's or Master's Degree in Science or Engineering
•At least eight (8) years of experience in the pharmaceutical industry within the Quality Operations Department