{"id":3803397,"url":"https://alion.io/job/zentiva-qualified-person-distribution","title":"Qualified Person - Distribution","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":82,"open_postings":7,"ghost_share":0,"stale_share":0.714,"repost_share":0,"time_to_fill_p50_days":44,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Sales","role_family":"Sales","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":["Prague, Czech Republic"],"countries":["CZ"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-05T12:29:12Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-05T18:27:32Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Ready to make an impact on quality beyond our walls? As Qualified Person, you will safeguard compliant medicinal product distribution and provide quality oversight across our external warehousing, logistics and customer network.\nThe Qualified Person establishes, describes, and documents the medicinal product distribution system, releases returned goods back into distribution, coordinates recalls, and decides on disposal.\nStep into a high-impact regulatory role where you’ll safeguard the timely availability of medicines, own the end-to-end GDP quality system, shape a new 3PL partnership, and collaborate within a truly international team.\nKEY RESPONSIBILITIES AND ACTIVITIES\nControl and completion of documentation, control of transport conditions, GDP distribution relase for products, already GMP certified by other EU QP \nPrepare, review and approve Quality Assurance Agreements\nReview and approve risk assessments, change controls, deviation and complaints investigations and their associated CAPAs\nSupport investigation process to ensure the timely evaluation of deviation and complaints and their escalation when needed\nEdit, review, approve GMP and GDP documents and internal procedures\nReview and approve Product Quality Reviews\nWorking with electronical systems (e.g. Quality Forward, eDMS, SAP)\nRegistration of approved suppliers/distributors and relevant GDP certificates\nSingle Point of Contact for the Local Health Authority in relation to Zentiva k.s. distribution activities\nSupport internal, external, customers audits and lead / assist during Health Authority Inspections as required\nQUALIFICATIONS & REQUIRED SKILLS\nUniversity degree with specialization in chemistry, industrial chemistry, biochemistry, or pharmacy\nAt least 5 years experience in quality area in pharmaceutical industry\nStrong knowledge of GMP and GDP processes and regulations, pharmaceutical quality assurance principles and regulatory requirements\nExperience with deviations, complaints, investigations, CAPAs, change controls, risk assessments, quality agreements, transport/storage excursions and audit/inspection support.\nExcellent analytical problem solving skills\nFlexibility and ability to manage competing priorities\nEffective communication and negotiation skills\nCollaborative, team-spirited, positive, and energetic person\nFluency in Czech and English proficiency level are mandatory\nWHY ZENTIVA\nAt Zentiva, our values guide the way we work every day: Accountability, Authenticity, Collaboration, Courage and Trus t. 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