Job ID :
3958
Company :
Damcosoft
Location :
foster city, CA
Type :
Hire
Duration :
6 Months
Status :
Active
Openings :
1
Posted :
5 years ago
Job Seekers, Please send resumes to resumes@hireitpeople.com or Call: (202) 719-0200 Ext: 127

Job Description

 

Validation - Auditing, Document Professional/Consultant

·         Knowledge with computer system validation experience.

·         Experience in writing and executing documentation for all aspects of the validation deliverables (etc.). Requirements, Compliance/validation Plans, test protocols.

·         Test Summary reports and Compliance/validation reports.

·         Experience in Software Development Lifecycle (SDLC).

·         Knowledge in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

·         Experience is creation of SOPs.

·         Knowledge of FDA guidance’s and industry standards (i.e., GAMP).

·         Strong verbal and written communication skills.                                                   

·         Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.