Job Description :
Strong Experience in Computer Systems Validation (CSV) within the Pharmaceutical industry.
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.
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
Thanks & Regards
Naresh Reddy
(Direct