Senior Metrology Specialist

Role Summary

The Senior Metrologist 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
• Responsible for performing all assigned activities within budget and schedule constraints

Qualifications

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