Quality Control-Laboratory Validations-Manati

Descripción del Empleo:
Evaluates documentation compliance for all Quality Control Laboratory instrument validation documents such as CR’s, SOP’s, URS, qualification and validation Protocols, validation plans according with government regulations and Company Policies. Reviews and approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated Quality Control Laboratory instrument, processes, and systems with respective reports. Reviews and approves the Process/Laboratory Performance qualification protocols, Traceability Matrix document, and Validations reports among others. Reviews and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation. Perform other duties that may be assigned.
Requisitos:
Minimum 6 years of experience working in Quality Control Laboratory instrument validations responsibilities in a regulated industry. Knowledge of laboratory instruments operations and background in pharmaceutical products manufacturing environment. Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping etc). Knowledge with network communications protocol (i.e. TCP/IP). Acquainted with GAMP5 methodology for validations. Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Trackwise and SAP. Fully bilingual. Willing to work irregular hours, rotative shifts, weekends and holidays when needed. Bachelor Degree in Science Completed. Qualified Candidate please send your resume to **********