{"id":958386,"url":"https://alion.io/job/zentiva-quality-systems-management-expert","title":"Quality Systems Management Expert","company":{"id":203016,"name":"Zentiva","domain":"zentiva.lv","url":"https://alion.io/company/zentiva","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":0.818,"repost_share":0,"time_to_fill_p50_days":44,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ankleshwar, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-09-16T07:29:06Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-13T05:40:04Z","board_verified":true,"closed_at":null,"days_open":57,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":57},"description":"Position title: Quality Systems Management Expert\nREQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS\nTechnical University Degree (health, pharma, technical, chemical areas are advantage)\n6 to 10 years industry experience specifically Quality Systems, Complaint Management, Events/Deviations, CAPA Management, Change Controls, eQMS administration or related GxP disciplines.\nOrganizational and analytical skills associated with proficiency in quality management and continuous improvement.\nCritical thinking ability and risk management and risk- based knowledge and approach.\nAbility in partnering with a proactive and solution- oriented approach.\nStrong skills to facilitate/optimize contribution of team members as individuals and members of a quality function\nAbility to work effectively in a matrix cross-functional environment.\nStrong capacity for working independently with minimal supervision.\nAbility to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)\nSelf-awareness, willingness to further develop own strengths and explore opportunities for improvement.\nJob Purpose:\nThe Quality Systems Management Expert is responsible for supporting quality system processes within the Quality Shared Services Centre (QSSC), including complaint management support, event tracking, CAPA and change control follow-up, document translation coordination, Quality Forward (QF) administration and compliance tracking activities.\nThe role provides operational support to affiliates, sites and quality functions by ensuring timely creation, maintenance, tracking and follow-up of quality records, actions and documentation. The role contributes to compliance, data integrity, inspection readiness and continuous improvement across quality management system processes.\nMAIN ACCOUNTABILITIES AND DUTIES\n Complaint Management SupportReceive, review, translate and process product quality complaints.\nCreate and maintain complaint records in Quality Forward (QF).\nForward complaints to the responsible entity for investigation and follow up on timely closure.\nMaintain complaint trackers and status reports.\n\nEvent, CAPA & Change Control CoordinationCreate and maintain event, CAPA and change control records in QF.\nMonitor progress, action items and closure timelines.\nFollow up on overdue actions and escalate delays where required.\nMaintain trackers, compliance dashboards and performance reports.\n\nInvestigation Review SupportPerform first-level review of investigation reports for completeness, consistency and supporting documentation.\nConsolidate and communicate review comments to responsible stakeholders.\nTrack resolution of review comments and follow-up actions\n\nQuality Forward AdministrationMaintain quality system records and ensure data integrity within QF.\nSupport workflow administration, document management and routine QF activities.\nGenerate reports, metrics and dashboards.\n\nCompliance Monitoring & ReportingMonitor complaints, events, CAPAs and change controls for compliance with established timelines.\nSupport KPI generation, trend monitoring and management reporting.\nEscalate recurring issues, overdue records and compliance risks.\nSupport identification of improvement opportunities based on complaint, deviation, CAPA and change control trend analysis.\n\nInspection Readiness & Continuous ImprovementMaintain inspection-ready records and documentation.\nSupport audits and inspections through provision of documentation and tracking information.\nParticipate in process harmonization, continuous improvement and digitalization initiatives.\n\nOTHER RESPONSIBILITIES\nQUALITY\nAdheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.\nHSE\nAdheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.\nPHARMACOVIGILANCE\nAll employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.\nCOMPLIANCE*\n*) country specific\nThe employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.\nSUSTAINABILITY\nAdheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet\nCOMMUNICATIONS & WORKING RELATIONSHIPS\nInternal\nCommunicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and shared services\nExternal\nCommunication with External suppliers.","description_format":"text","description_chars":5122,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-09-16T07:29:06Z"}],"visa":[],"liveness":{"score":32,"band":"fade","label":"Fading","p_open":1,"p_active":0.573,"p_room":0.55,"age_days":57,"expected_fill_days":44,"reasons":["conf:12","stale_co","velocity","win:tail"],"computed_at":"2026-11-12T10:38:37Z"},"pay":null,"html_url":"https://alion.io/job/zentiva-quality-systems-management-expert","json_url":"https://alion.io/job/zentiva-quality-systems-management-expert.json","meta":{"generated_at":"2026-11-13T06:09:26Z","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":13012,"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":203016},"rest":"https://alion.io/mcp/rest/get_company?id=203016"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzentiva-quality-systems-management-expert"},{"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%2Fzentiva-quality-systems-management-expert"},{"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%2Fzentiva-quality-systems-management-expert"},{"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/zentiva-quality-systems-management-expert\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzentiva-quality-systems-management-expert"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":958386}},{"tool":"search_jobs","arguments":{"company":"zentiva.lv","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":958386},"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. 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