Capa Coordinator

Job Description Description Perform trend analysis, review and approval of investigations reports. Follow up of commitments up to closure of investigations. Perform final review and determine acceptability by using product specifications, Master Batch Records, procedures and applicable documentation concerning to the manufacturing process and quality system elements. Support the quality monthly metrics presented inside and outside of Baxter Guayama. Coordinate the CRB and Management Review meetings and the Quality Quotient approach. Qualifications The candidate to fulfill this position needs to be capable of evaluating investigation reports considering all regulatory aspects to assure the same are adequate and complete. Need to have a wide GMP Knowledge and capable to perform trends to alert for actions to be taken and or potential risks. Leadership skills and quality oriented. Excellent oral/written communications and interpersonal skills. Ability to communicate at all levels within the organization. Good technical reports writing. Able to work under minimum supervision. Fully bilingual (written and verbal English and Spanish). Computer literate: PC Knowledge(Word, Excel and Power-point). Education: Essential: Requires a B.S. Degree in Science. Job Experience: Essential: At least three years of experience in the pharmaceutical industry. Desirable: Statistical knowledge and quality monitoring