Aerospace & Defence Manager (Permanent)
3 giorni fa
Napoli, Provincia di Napoli; Campania, Italia
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As Metrology Manager at Sanofi's Goa GMP site, you lead the site-wide metrology and calibration program to ensure instruments stay accurate, traceable and compliant. You will collaborate with Engineering, Quality, Validation and Manufacturing to maintain calibration readiness and drive continuous improvements. You'll manage external calibration partners and coordinate with NABL labs to uphold GMP data integrity. This role offers exposure to regulatory inspections, equipment qualification and cross-functional problem solving. You will shape metrology practices that support product quality and patient safety.
Lead the site-wide metrology and calibration program for measuring and test equipment
Plan, schedule and coordinate calibration activities to ensure timely completion and compliance
Define and review calibration frequencies and acceptance criteria based on equipment criticality
Maintain audit-ready calibration records in CMMS/SAP and ensure GMP/data integrity compliance
Ensure metrology activities comply with cGMP/GxP/GDP and regulatory requirements; lead or support deviation investigations and CAPA related to measurement systems
Participate in Change Control for equipment/measurement system modifications; support QA in CAPA closure
Provide metrology input for IQ/OQ/PQ, equipment qualification and requalification
Develop and update SOPs, training and drive continuous improvement in metrology processes
Coach and develop metrology staff to ensure GMP/HSE compliance and engineering competencies
Engage with cross-functional teams to ensure timely implementation of corrective and preventive actions
Contribute to metrology-related decisions in deviations, OOT investigations, and external vendor management
Ensure safety and site procedures alignment across all metrology activities
Bachelor's degree in Electrical & Electronics Engineering with 5+ years of metrology management in pharma OR Diploma in Electrical & Electronics Engineering with 10+ years in pharma metrology management
Strong hands-on experience in GMP manufacturing metrology and calibration
Experience managing a site-wide calibration/metrology program (preferred)
Knowledge of metrology principles and calibration practices for temperature, pressure, flow, pH, conductivity and weighing systems
Experience with IQ/OQ/PQ and equipment qualification/requalification; Experience with NABL-accredited labs/service providers and ensuring traceability to standards
Proficiency in SAP or other CMMS systems
Understanding of cGMP/GxP, data integrity and regulatory inspections; Strong communication, analytical, problem-solving and stakeholder management skills
Ability to collaborate with Engineering, Quality, Validation and Manufacturing teams
Metrology principles and calibration practices
Temperature, pressure, flow, pH, conductivity and weighing systems
IQ/OQ/PQ and equipment qualification/requalification
Metrology Manager napoli, campania, it