We are sourcing a contractor to perform on site services as the technical specialist to review and approve product MP’s, approve process validation protocols and reports for manufacturing processes, represent Quality on incident triage team, approve Environmental Characterization reports, release of sanitary utility systems, approve planned incidents, represent QA on NPI team, lead investigations, own site quality program procedures, designee for QA manager on local CCRB.
Must have: Bachelor’s degree and 8 years of directly related with Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing, and negotiating, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development. Demonstrated ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong (English/Spanish) communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues.
Contacto - Contact
Sara P. Odeh Torres
sodeh@alpharmapr.com
Puerto Rico
