Senior Metrology Specialist

Role Summary

The Metrology Specialist is responsible for a variety tasks related to calibrations of equipment, managing and overlooking equipment change requests in a timely manner. Contacts vendors, when needed, and coordinates their activities.

Responsibilities

• Responsible for effective and efficient calibration to ensuring compliance with Novartis quality standards and applicable CGMP regulations.
• Facilitates instrumentation calibration/qualification with external vendors, internal and/or external resources and local system owners
• Supports the preparation of equipment binders containing technical & qualification Novartis life cycle documents & required vendor documents, IQ/OQ/PQ Protocols, and Summary Reports for qualification of QC equipment
• Ensure compliance to cGMP, regulatory regulations and Novartis global and local policy for equipment
• Develop / review appropriate SOPs and corresponding Forms
• Responsible for performing all assigned activities within budget and schedule constraints
• Ensure communication flow in the Analytical Service team and with all individual involved in the process (e.g. Value Stream (Make- Test- Release) team.
• As subject matter expert provide support during audit and inspections

Qualifications

• High School degree required; BS/BA degree in Engineering or the life sciences or other related field is preferred.
• 3+ years of relevant experience is required.
• Relevant calibration experience, or applicable experience in a related area, is required.
• Previous GMP experience is required.
• Previous experience in pharmaceutical industry.