14 set - Biella
Sanofi
Overview
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.
Responsabilità
- 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
- Manage calibration of critical process and analytical instruments (temperature, pressure, flow, pH, conductivity, weighing)
- 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
- Coordinate with NABL-accredited calibration service providers; review certificates and ensure traceability
- Support qualification, evaluation and periodic review of external calibration providers
- Ensure metrology activities comply with cGMP/GxP/GDP and regulatory requirements; maintain audit readiness
- Support regulator and internal audits; 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
- Support preventive maintenance and troubleshooting to improve reliability and minimize downtime
- 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
Requisiti fondamentali
- 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; temperature mapping knowledge
- 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; supporting audits
- Strong communication, analytical, problem-solving and stakeholder management skills
- Ability to collaborate with Engineering, Quality, Validation and Manufacturing teams
- Strong communication skills
- Stakeholder management
- Analytical and problem-solving abilities
- Metrology principles and calibration practices
- Temperature, pressure, flow, pH, conductivity and weighing systems
- IQ/OQ/PQ and equipment qualification/requalification
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