-APPROVES PROTOCOLS, MASTER PRODUCTION BATCH RECORDS, STANDARD OPERATING PROCEDURES (SOPS), AND SAMPLING PLANS IN SUPPORT OF MANUFACTURING OPERATIONS -COORDINATES WITH MANUFACTURING TO ENSURE APPROPRIATE IMPLEMENTATION OF CHANGES TO PROCESSES AND SYSTEMS REVIEWS AND VERIFIES DEVIATION NOTICES GENERATED BY THE QA DEPR DURING MANUFACTURING, INCLUDING RESOLUTIONS AND CORRECTIVE ACTIONS -PARTICIPATES IN THE MATERIAL REVIEW PROCESS TO EVALUATE PROPER DISPOSITION OF NONCONFORMING MATERIALS -PROVIDES TECHNICAL SUPPORT AND OVERSIGHT THROUGH THE QA REPRESENTATIVES AND DIRECTLY WITH THE PLANT AND SITE MANAGEMENT, MANUFACTURING PERSONNEL, AND OTHER SITE QUALITY DEPARTMENTS
-UNIVERSITY DEGREE IN A RELEVANT SCIENCE (PHARMACY, CHEMISTRY, BIOCHEMISTRY, BIOLOGY, ETC) A POST GRADUATE DEGREE WILL BE CONSIDERED AN ASSET -MIN 5 YEARS OF EXPERIENCE IN A QUALITY ASSURANCE DEPARTMENT OF AN ORGANIZATION -MIN. 5 YEARS EXPERIENCE IN CGMP