{"id":3418203,"url":"https://alion.io/job/hikma-pharmaceuticals-sr-specialist-quality-engineer","title":"Sr. Specialist, Quality Engineer","company":{"id":1843927,"name":"Hikma Pharmaceuticals","domain":"hikma.com","url":"https://alion.io/company/hikma","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Zagreb, Croatia"],"countries":["HR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":34000,"max_usd":76000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8444},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-28T18:07:55Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-05T22:20:18Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"Senior Specialist, Quality Engineer (m/f/d)\nLocation: Zagreb\nHikma Pharmaceuticals purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 9 R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.\nAs a Senior Specialist, Quality Engineer in the R&D Quality department, you will support the implementation and maintenance of Quality Management system for Combination Products in R&D to ensure full compliance with 21 CFR part 4, 210, 211, ISO 13485, ISO 14971, and IEC 62366.Working closely with cross-functional stakeholders, you will contribute to quality oversight activities and help foster a culture of quality, compliance, and continuous improvement through project development lifecycle.\nKey responsibilities:\nResponsibility for R&D Quality activities during the development and pre-approval phase of the products and their lifecycle\nDevelop and maintain Quality Management System for Combination Products in R&D\nTraining responsible person (preparation of training plan and status, matrix and LMS Curricula)\nMonitor compliance, quality assurance and regulatory requirements and evaluate their impact on defined processes in R&D\nIdentify continuous improvement initiatives inquality and compliance related processes in R&D\nProvide scientific and structural support to the R&D team on:\nReview/approve of different product related documentation (external and internal)\nReview/approve of design control documentation (21 CFR 820.30)\nReview/approve of different risk assessments (including ISO 14971, FMEA, fault tree analysis)\nSupport activities of technology transfer (R&D to manufacturing)\nProvide Change control/deviation/OOS/CAPA support during exhibit batch production and submission phase\nSupporting deficiency letters responses received by Authorities\nAssure high quality of QA documentation\nParticipate in all kinds of audits (internal, corporate and external audits)\nParticipate in due diligences of potential external collaborators\nSupplier assessment/vendor evaluation in development phase\nParticipation in GMP equipment qualifications\nMentoring of new employees in R&D Quality \nStays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed, for supporting audit preparation at site.\nWhat we expect:\nBachelor’s degree in Life Sciences, engineering or equivalent\nMinimum of 5 years of experience in Combination products or Medical Devices area in the pharmaceutical industry\nExperience with GDocP systems (e.g., Veeva, electronic notebooks)\nStrong verbal and written communication skills (Intermediate Level in English is a must)\nDemonstrated expert knowledge of 21 CFR, ICH, cGMPs, USP, current FDA regulations, Ph. Eur., current EMEA regulations\nStrong collaboration, communication, problem-solving and decision-making skills\nProactive mindset with a focus on continuous improvement and delivering results\nWhat do we offer:\nCollaboration across teams and functions, building relationships with colleagues from different departments and regions\nIndividual contributor role with high autonomy, visibility and influence\nOn-site work with the opportunity to work from home one day per week\nCompetitive compensation and benefit package\nIf you are collaborative, like to innovate in the way you work, care about others, and are interested in a career where you can make a positive impact on people’s lives, apply no later than October 18th, 2026.","description_format":"text","description_chars":3588,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Croatia","iso":"HR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Generic Drugs","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-28T20:10:50Z"}],"visa":[],"liveness":{"score":79,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.831,"p_room":0.945,"age_days":7,"expected_fill_days":11,"reasons":["conf:4","win:mid"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/hikma-pharmaceuticals-sr-specialist-quality-engineer","json_url":"https://alion.io/job/hikma-pharmaceuticals-sr-specialist-quality-engineer.json","meta":{"generated_at":"2026-11-06T00:01:43Z","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":82,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":1843927},"rest":"https://alion.io/mcp/rest/get_company?id=1843927"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhikma-pharmaceuticals-sr-specialist-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fhikma-pharmaceuticals-sr-specialist-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fhikma-pharmaceuticals-sr-specialist-quality-engineer"},{"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/hikma-pharmaceuticals-sr-specialist-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhikma-pharmaceuticals-sr-specialist-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3418203}},{"tool":"search_jobs","arguments":{"company":"hikma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3418203},"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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