PHARMA QUALITY DIRECTOR

Job Description : PHARMA QUALITY DIRECTOR ROMANIA Open to International candidates with 25+ years experience Quality Management Director is a strategic role in ensuring GxP conformity at the organizational level, coordinating the quality management system and promoting organizational culture to excel and be responsible. îmbun?t??ire continu?. This will ensure that the quality management system is continued, in accordance with GMP, GDP and other applicable standards. Monitorizeaz? performan?a system main KPI, internal audituri ?i Quality Management Review Coordinate quality documents (SMF, Manualul Calit??ii, SOP-uri, politici) ????Leadership and organizational culture Dezvolt? ?i promoveaz? culture qual??ii the toate levelurile organizations Create a medium orientation is transparent, responsible for compliance with non-conformity Coordinate between dezvolt? equipment QA and QC ????Control, conform to critical processes Supervise management of devia?iilor, OOS/OOT, CAPA and Change Control Monitorizeaz? process of releasing loturilor ?i, in role of Persoan? Qualificat?, poate release loturi Assures that the data is integrated and conforms to the GxP cerin?ele Coordinate internal and external audits (including furnizori) Asigur? „audit readiness” permanent pentru inspec?iile ANMDMR, EMA, EAEU Supervise post-inspection post-inspection and implement corrective action ????Validate, risc ?i îmbun?t??ire continu? Coordinate the validation and qualification process (technically, process, IT system) Quality risk management (FMEA, HACCP) Optimize the process for increased efficiency and reduction of risk Reprezint? company in relation to the authoritative of I will regulate Assure continued conformity with national and international legislative certiorari Higher studies in pharmacy, chemistry, chemical engineering, biology and medicine Certificare Persoan? Qualificat? (QP) Experience of minimum 10 years in pharmaceutical industry and 5 years in leadership role in quality Cuno?tin?e avansate GMP, GDP, ISO 9001 ?i cerin?e GxP Experience solidity QMS management and GMP audits Leadership puternic ?i experien?? în coordonarea echipelor complexe Train yourself in analysis and investigation (RCA, 5 Why, Fishbone) Experien?? în managementul riscurilor (FMEA, HACCP) Limba englez? – advanced level Integrit yourself with professional ethics Gândire strategic? ?i oriente spre solu?ii Rezilien?? ?i capacitate de cizie sub presiune Excellent ability to communicate and influence Orientare c?tre îmbun?t??ire continu? ?i culture calit??ii

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