Principal Engineer – IT QA & CSV

RxLogix is an innovative company developing cutting edge software products for the pharmaceutical industry. We are seeking passionate candidates to join our QA team in Noida, India. We offer competitive salaries, and other benefits to make sure everyone here has a stake in our success.

Requirements

• BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic score
• IT Quality Assurance professional with 6 years of hands-on experience with computerized system validation in life sciences industry
• Pharmaceutical/Life Sciences/ Medical Devices background
• Understanding of risk-based system validation approach
• Review of SDLC product documents from content perspective
• End to end understanding of regulatory guidelines and required documentation for new system release
• Regulatory/ client audit experience on IT systems
• Worked in evolving the IT-QMS and possesses SOP/Template authoring experience
• Guide the product/project team on the CSV impact for all the change controls
• Knowledge of GxP, QA best practices
• In depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA
• In depth understanding of 21 CFR Part 11, EU Annex 11 compliance
• In depth understanding of the implementation methodology for GxP system in accordance to CSV compliant model
• Experienced in Documentation authoring, reviewing and requirement analysis
• Should have extensive reviewing experience on the CSV documentation – CR, VP, URS, TP/QP, CSD, TSR, VSR, RTM
• Well-organized and detailed oriented professional, with strong verbal and written communication skills
• Must be self- motivated with ability to handle, organize and prioritize multiple tasks
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner
• Should be able to achieve the optimum balance for Quality v/s Productivity
• Experience in client interaction and client handling

Benefits

• Competitive salaries
• Other benefits