In this role you oversee site validation and qualification activities to ensure products meet quality standards within GMP guidelines. You provide regulatory-aligned oversight across equipment, processes, utilities, and computerised systems, supporting Data Integrity and CSV governance. You lead risk-based validation strategies, drive continuous improvement, and collaborate with cross-functional teams to sustain safe, compliant operations. This position offers impact in a global manufacturing network and a chance to shape site quality programs.Scopra di più su questo ruolo leggendo le informazioni qui sotto, quindi invii la sua candidatura per essere preso/a in considerazione.annual bonuspensionprivate medical insuranceremote work optionsSupport Quality Management in budgeting for departmental projects and initiativesContribute to workforce planning by assessing FTEs and required competenciesDefine and maintain internal structure with roles, responsibilities, and job assignmentsSet and align qualitative and performance objectives with the MBO systemPromote team development through targeted training and coachingEnsure personnel alignment with corporate competencies and behaviorsMonitor compliance with values, code of conduct, ethical standards, and legal/contractual requirementsManage personnel in line with labor laws and health and safety regulations; coordinate team activitiesEnsure operational efficiency and safety of departments, facilities, and equipment; oversee maintenancePropose investments to maintain safety, compliance, and operational effectivenessEnsure mandatory safety training and information disseminationCollaborate on departmental Risk Assessment Document (DVR) updatesImplement risk controls and emergency proceduresEnsure proper use of PPE and timely replacementsReport irregularities posing health and safety risksOversee Validation Project Plans (VPP) and Validation Final Reports (VFR)



developmentSupervise Technology Transfer documentation for regulatory complianceLead validation/qualification activities with objectives and timelines; review data and corrective actionsQA review of validation docs (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV)Investigate qualification deviations and assess regulatory impactManage environmental and cleaning validation programsEnsure GDP-compliant pharmaceutical transport validationSupport new site projects with regulatory-aligned validation strategiesContribute to process verification planning and documentationCoordinate CSV and Data Integrity review activitiesSupport risk assessments to define CPPs/CQAs and validation strategiesCoordinate cross-functional risk assessments for regulatory submissionsCollaborate with Production to align GMP and production plansSupport CAPA from audits/inspections; participate in self-inspections and auditsMaintain Validation Master Plan and Validation Change Control ProgramAct as SME for process validation topics; deliver training on Validation processesDrive continuous improvement to streamline validation and xysqume reduce non-value-added activitiesProvide leadership for validation-related CAPA activitiesParticipate in Quality Risk Management and FMEA activities as Validation SME8-10 years of experience in pharma or biopharma manufacturingExtensive experience in validation and qualification of equipment and systems in cGMP environmentsStrong knowledge of EU and FDA regulatory requirements; exposure to regulatory inspections (e.G., FDA/DEA)Ability to define and execute multi-project strategiesSolid technical problem-solving and risk assessment skillsHigh initiative, accountability, and ability to work with minimal supervisionExcellent teamwork and interpersonal skills across organizational levelsleadershipteam collaborationcommunicationValidation, Qualification & ComplianceGMPCSV (Computerised System Validation)Validation & Equipment Compliance Manager parma, emilia romagna, it#J-18808-Ljbffr

📌 Validation & Equipment Compliance Manager (Parma)
🏢 Chiesi
📍 Parma