Quality Assurance Compliance Officer
il y a 8 heures
OverviewJust-Evotec Biologics EU is looking for a motivated Quality Assurance Compliance Officer to join the team in an indeterminate contract (CDI) as part of building a biotechnological production site. The role reports to the Quality Assurance Compliance Manager and contributes to preparing the site for health authority inspections and managing health authority inspections and client audits. The description is provided in both French and English.ResponsibilitiesCoordinate end-to-end inspection readiness activities, including preparation and strategy sessions, instructor-led training and managing audit/inspection related logisticsEnsure site personnel readiness through training and coaching sessions with expertsCoordinate cross-functional activities focusing on development, review, approval and submission of responses for inspection and audit findingsMonitor and report on the status of remediation actions resulting from audit and inspection findings and drive efforts to ensure on-time completionReview, analyze and distribute regulatory inspection and client audit data and trending issued by regulatory authorities to ensure proactive compliance within the organizationDevelop and manage the inspection readiness annual plan, including the identification of anticipated inspectionsParticipate in inspections and client audits to provide regulatory supportWrite and maintain procedures within your scope and propose improvements to the quality management system for biologics in line with GMP requirementsSet up appropriate work tools to carry out missions (dashboards, reporting tools)Contribute to managing the site's compliance with regulatory authorities, by participating in annual declarations and managing modifications (annual site master file updates and drug substance file)Contribute to managing the compliance of production activities with respect to Marketing Authorization dossiers, in liaison with clients (MA management, variation management, transposition into operational documents)Knowledge and SkillsDirect experience of health authority inspections, client audits or internal audits in a GMP environmentGood knowledge of French and international regulations (e.g. GMP parts I and II, appendix 1 and 2, 21CFR Parts 11, 600, 820...)Good knowledge of production and quality management processesExcellent level of written and spoken English (C1-C2)Excellent writing skillsSoft SkillsExcellent oral and written communication skills, ability to convey technical information clearly and conciselyRigor, attention to detail and organization, patienceStrong team spirit, good interpersonal skills and listening abilityAbility to work under pressure and meet tight deadlinesAnalytical and summarizing skills, proactivity for continuous improvementAdaptability while promoting a GMP mindsetAutonomy and versatilityAppreciation of cultural diversityExperience and TrainingEducation: Bac +5 (Master 2) with a specialization in pharmaceutical regulatory affairs, quality management or compliance in the pharmaceutical/biotechnology fields.Experience: 2 to 5 years in a similar position in the pharmaceutical/biotechnology sectors.Diversity and InclusionFR: Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.ENG: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities. #J-18808-Ljbffr
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