Job Code : BSA-19-0005
Positions : 1
Job Type : Full Time
Location : Chicago, Illinois, USA
Key Skills :
5 years ago
Job
Description:
Strong
Experience in Computer Systems Validation (CSV) within the Pharmaceutical
industry.
• Required Bachelor's degree in pharmaceutical Science OR related field of study.
•
Schedule and plan equipment and process qualification workload to meet approved
schedules.
•
Handle multiple projects and be able to work independently as required.
•
Develop GxP system lifecycle documentation, including Validation Plans, User
Requirements Specifications, Functional Design Specifications, Configuration
Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance
testing, Traceability matrix, System and Validation reports, SOPs, Change
Control Documentation, and Risk assessment/FMEA reports as required.
•
Establish critical parameters, plan, design, and implement validation projects
and protocols.
•
Ability to author, execute, and thoroughly review complex protocols and
documentation.
•
Coordinate validation activities with other departments.
•
Stay current with industry qualification trends through FDA, ISPE, EU and bench
marked companies.
•
Consult, coordinate, cross-function with various personnel within the company
and externally.
•
Have the ability to problem solve with minimal oversight, including conducting
research to aid in the resolution of issues that arise.
•
Train and mentor other Validation personnel as necessary.
•
Determine and acquire necessary supplies and equipment for validation
activities (Planning).
•
Administer the site Change Control/Management Program.
•
Make decisions representing QA in multi-functional teams.
•
Plan and assist with the Global serialization project (as necessary).
•
Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is
desirable