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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | IT - Software |
Functional Area | Testing |
EmploymentType | Full-time |
JOB DESCRIPTON: - The candidate responsibilities include mainlyMaintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.Organize and maintain supplies for testing.Oversee all testing, including special project / protocol testing in a timely and appropriate manner.Perform laboratory and manufacturing audits as required. Audit and update, as required, lab SOPsInvestigate deviations and write exception documents.Participate in functions improvement teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.Ensure equipment maintenance and calibration, and internal audits are performed on schedule.Use sophisticated laboratory instrumentation and computer systems to collect and record data.Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.Minimum Diploma or relevant work experience in information systems, engineering or science.Highly skilled in Computerized System testing and validation in the healthcare industry.Knowledge of GxP regulations (e.g. 21 CFR Part 11, etc.) Ability to multi - task. Must have strong analytical problem solving skills. Excellent communication including written, verbal, and listening skills. Self - motivated, detail oriented, takes initiative and ability to work without close supervision.,
Keyskills :
roblem solving business analysis system testing internal audit