Principal Engineer – IT QA & CSV

Summary 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.

We're a fast-growing organization looking for talented people to take on big, ambitious projects and deliver amazing results.

Description Note : This opportunity is not a fit for the software testing professionals.

The candidate must possess experience in the Pharmaceutical IT Compliance areas/CSV.

Provide application validation expertise on GxP products for drug safety space.

Be accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.

Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME. Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories. Should have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management. Closely work with clients and product owners to support implementation and resolve product quality issues. Must Have Qualifications 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 Desirable Qualifications Exposure to pharmacovigilance domain and drug safety applications – Argus or ArisG/J – strong preference Experience with electronic document management system is a plus.