10 ott - Parma
Chiesi
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. annual premio pension private medical insurance remote work options Support Quality Management in budgeting for departmental projects and initiatives Contribute to workforce planning by assessing FTEs and required competencies Define and maintain internal structure with roles, responsibilities, and job assignments Set and align qualitative and performance objectives with the MBO system Promote team development through targeted training and coaching Ensure personnel alignment with corporate competencies and behaviors Monitor compliance with values, code of conduct, ethical standards, and legal/contractual requirements Manage personnel in line with labor laws and health and safety regulations; coordinate team activities Ensure operational efficiency and safety of departments, facilities, and equipment; oversee maintenance Propose investments to maintain safety, compliance, and operational effectiveness Ensure mandatory safety training and information dissemination Collaborate on departmental Risk Assessment Document (DVR) updates Implement risk controls and emergency procedures Ensure proper use of PPE and timely replacements Report irregularities posing health and safety risks Oversee Validation Project Plans (VPP) and Validation Final Reports (VFR)
development Supervise Technology Transfer documentation for regulatory compliance Lead validation/qualification activities with objectives and timelines; review data and corrective actions QA review of validation docs (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) Investigate qualification deviations and assess regulatory impact Manage environmental and cleaning validation programs Ensure GDP-compliant pharmaceutical transport validation Support new site projects with regulatory-aligned validation strategies Contribute to process verification planning and documentation Coordinate CSV and Data Integrity review activities Support risk assessments to define CPPs/CQAs and validation strategies Coordinate cross-functional risk assessments for regulatory submissions Collaborate with Production to align GMP and production plans Support CAPA from audits/inspections; participate in self-inspections and audits Maintain Validation Master Plan and Validation Change Control Program Act as SME for process validation topics; deliver training on Validation processes Drive continuous improvement to streamline validation and reduce non-value-added activities Provide leadership for validation-related CAPA activities Participate in Quality Risk Management and FMEA activities as Validation SME 8-10 years of experience in pharma or biopharma manufacturing Extensive experience in validation and qualification of equipment and systems in c GMP environments Strong knowledge of EU and FDA regulatory requirements; exposure to regulatory inspections (e.g., FDA/DEA) Ability to define and execute multi-project strategies Solid technical problem-solving and risk assessment skills High initiative, accountability, and ability to work with minimal supervision Excellent teamwork and interpersonal skills across organizational levels leadership team collaboration communication Validation, Qualification & Compliance GMP CSV (Computerised System Validation) Validation & Equipment Compliance Manager parma, emilia romagna, it
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