Principal Engineer – IT QA & CSV

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    "datePosted": "2022-06-16",
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    "description": "<p><span style=\"font-weight: bold;\"><span style=\"color: #222222; font-size: 18px;\">Summary</span></span></p>\r\n<p><span style=\"color: #222222; font-size: 15px;\">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.</span></p>\r\n<p><span style=\"color: #222222; font-size: 15px;\">We're a fast-growing organization looking for talented people to take on big, ambitious projects and deliver amazing results. </span></p>\r\n<p><span style=\"color: #222222; font-size: 15px;\"> </span></p>\r\n<p><span style=\"font-weight: bold;\"><span style=\"color: #222222; font-size: 18px;\">Description</span></span></p>\r\n<p><span style=\"font-weight: bold;\"><em><span style=\"color: #222222; font-size: 15px;\">Note</span></em></span><span style=\"color: #222222; font-size: 15px;\">: This opportunity is <span style=\"font-weight: bold;\">not</span> a fit for the software testing professionals. The candidate must possess experience in the Pharmaceutical IT Compliance areas/CSV.</span></p>\r\n<p><span style=\"color: #222222; font-size: 15px;\"> </span></p>\r\n<ol>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Provide application validation expertise on GxP products for drug safety space.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Be accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Requirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Should have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Closely work with clients and product owners to support implementation and resolve product quality issues.</span></li>\r\n</ol>\r\n<p><span style=\"color: #222222; font-size: 15px;\"> </span></p>\r\n<p><span style=\"font-weight: bold;\"><span style=\"color: #222222; font-size: 18px;\">Must Have Qualifications</span></span></p>\r\n<ol>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic score</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">IT Quality Assurance professional with <span style=\"font-weight: bold;\">6 years</span> of hands-on experience with computerized system validation in life sciences industry</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Pharmaceutical/Life Sciences/ Medical Devices background</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Understanding of risk-based system validation approach</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Review of SDLC product documents from content perspective</span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">End to end understanding of regulatory guidelines and required documentation for new system release</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Regulatory/ client audit experience on IT systems</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Worked in evolving the IT-QMS and possesses SOP/Template authoring experience</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Guide the product/project team on the CSV impact for all the change controls</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Knowledge of GxP, QA best practices</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">In depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA</span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">In depth understanding of 21 CFR Part 11, EU Annex 11 compliance</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">In depth understanding of the implementation methodology for GxP system in accordance to CSV compliant model</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Experienced in Documentation authoring, reviewing and requirement analysis </span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Should have extensive reviewing experience on the CSV documentation – CR, VP, URS, TP/QP, CSD, TSR, VSR, RTM </span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Well-organized and detailed oriented professional, with strong verbal and written communication skills</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Must be self- motivated with ability to handle, organize and prioritize multiple tasks</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Should be able to achieve the optimum balance for Quality v/s Productivity</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Experience in client interaction and client handling</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n</ol>\r\n<p><span style=\"font-weight: bold;\"><span style=\"color: #222222; font-size: 18px;\">Desirable Qualifications</span></span></p>\r\n<ol>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Exposure to pharmacovigilance domain and drug safety applications – Argus or ArisG/J – strong preference</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Experience with electronic document management system is a plus.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Experience with training coordination and management.</span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Worked in Agile / Scrum team structure</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Experience in SQL and PLSQL writing</span></li>\r\n</ol>\r\n<p><br></p>\r\n<p><span style=\"font-weight: bold;\"><span style=\"color: #222222; font-size: 18px;\">Duties and Responsibilities:</span></span><span style=\"color: #222222; font-size: 18px; font-family: Arial, sans-serif;\"> </span></p>\r\n<ol>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Reviewing the CSV documentation - VP, URS, Test Plan, CSD, IQ, OQ, PQ, TSR, VSR, RTM for RxLogix products and projects in PV domain</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Organize and ensure accurate and reliable filing for the paper-based GxP documents</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Assist in Quality Investigations and CAPAs</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Support Internal and Client audits on IT-QMS and IT Products</span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Provide first level of guidance and support to the project teams on CSV approach required for a planned change to a GxP system</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Participates in internal product audits and supporting external audits.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Processes and provides timely and accurate update on the assigned duties to the reporting manager.</span><span style=\"color: #222222; font-size: 15px;\"></span></li>\r\n<li><span style=\"color: #222222; font-size: 15px;\"> </span><span style=\"color: #222222; font-size: 15px;\">Participates in the revision, review, and approval of SOPs and controlled templates.</span></li>\r\n</ol>",
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