{"id":2689125,"url":"https://alion.io/job/rxlogix-principal-engineer-it-qa-csv","title":"Principal Engineer – IT QA & CSV","company":{"id":686929,"name":"RxLogix","domain":"rxlogix.com","url":"https://alion.io/company/rxlogix","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"BambooHR","truth_index":{"grade":"D","score":40,"open_postings":12,"ghost_share":1,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Noida, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":15500,"max_usd":39000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":14},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Agile","optional":true},{"name":"Scrum","optional":true},{"name":"SQL","optional":true}],"status":"live","first_seen_at":"2022-06-16T00:00:00Z","employer_posted_date":"2022-06-16","last_verified_at":"2026-11-12T16:48:40Z","board_verified":true,"closed_at":null,"days_open":1611,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":1610},"description":"Summary\nRxLogix 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.\nWe're a fast-growing organization looking for talented people to take on big, ambitious projects and deliver amazing results.\nDescription\nNote: This opportunity is nota fit for the software testing professionals. The candidate must possess experience in the Pharmaceutical IT Compliance areas/CSV.\nProvide application validation expertise on GxP products for drug safety space.\nBe accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.\nRequirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME.\nReviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.\nShould have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management.\nClosely work with clients and product owners to support implementation and resolve product quality issues.\nMust Have Qualifications\nBE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic score\nIT Quality Assurance professional with 6 yearsof hands-on experience with computerized system validation in life sciences industry\nPharmaceutical/Life Sciences/ Medical Devices background\nUnderstanding of risk-based system validation approach\nReview of SDLC product documents from content perspective\nEnd to end understanding of regulatory guidelines and required documentation for new system release\nRegulatory/ client audit experience on IT systems\nWorked in evolving the IT-QMS and possesses SOP/Template authoring experience\nGuide the product/project team on the CSV impact for all the change controls\nKnowledge of GxP, QA best practices\nIn depth understanding of the regulatory guidelines for IT systems- primarily FDA, EMA, MHRA and PMDA\nIn depth understanding of 21 CFR Part 11, EU Annex 11 compliance\nIn depth understanding of the implementation methodology for GxP system in accordance to CSV compliant model\nExperienced in Documentation authoring, reviewing and requirement analysis \nShould have extensive reviewing experience on the CSV documentation - CR, VP, URS, TP/QP, CSD, TSR, VSR, RTM \nWell-organized and detailed oriented professional, with strong verbal and written communication skills\nMust be self- motivated with ability to handle, organize and prioritize multiple tasks\nProven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner\nShould be able to achieve the optimum balance for Quality v/s Productivity\nExperience in client interaction and client handling\nDesirable Qualifications\nExposure to pharmacovigilance domain and drug safety applications - Argus or ArisG/J - strong preference\nExperience with electronic document management system is a plus.\nExperience with training coordination and management.\nWorked in Agile / Scrum team structure\nExperience in SQL and PLSQL writing\nDuties and Responsibilities:\nReviewing the CSV documentation - VP, URS, Test Plan, CSD, IQ, OQ, PQ, TSR, VSR, RTM for RxLogix products and projects in PV domain\nOrganize and ensure accurate and reliable filing for the paper-based GxP documents\nAssist in Quality Investigations and CAPAs\nSupport Internal and Client audits on IT-QMS and IT Products\nProvide first level of guidance and support to the project teams on CSV approach required for a planned change to a GxP system\nParticipates in internal product audits and supporting external audits.\nProcesses and provides timely and accurate update on the assigned duties to the reporting manager.\nParticipates in the revision, review, and approval of SOPs and controlled templates.","description_format":"text","description_chars":4056,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Healthcare & Life Sciences Consulting","Scientific & Lab Software"],"lifecycle":[{"event":"open","at":"2026-10-16T08:32:14Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":3,"green_card_filings_12m":0,"median_offered_wage_usd":137500,"route":null,"cap_exempt":false,"checked_at":"2026-11-12T07:36:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":6,"band":"cold","label":"Long shot","p_open":1,"p_active":0.202,"p_room":0.28,"age_days":1610,"expected_fill_days":31,"reasons":["conf:0","stale_co","ghost","win:tail","crowd:"],"computed_at":"2026-11-12T10:38:37Z"},"pay":null,"html_url":"https://alion.io/job/rxlogix-principal-engineer-it-qa-csv","json_url":"https://alion.io/job/rxlogix-principal-engineer-it-qa-csv.json","meta":{"generated_at":"2026-11-13T00:41:53Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":1541,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":686929},"rest":"https://alion.io/mcp/rest/get_company?id=686929"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Frxlogix-principal-engineer-it-qa-csv"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Frxlogix-principal-engineer-it-qa-csv"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Frxlogix-principal-engineer-it-qa-csv"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/rxlogix-principal-engineer-it-qa-csv\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Frxlogix-principal-engineer-it-qa-csv"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2689125}},{"tool":"search_jobs","arguments":{"company":"rxlogix.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2689125},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}