Supervisor- Calibration/ Metrology
3 weeks ago
Company Description
WE ARE SGS - THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.
**Job Description**:
Supervisor
- Calibration/ Metrology, is responsible for supporting and coordinating the work of the Validation / Metrology group to ensure that equipment is qualified, maintained and calibrated properly on schedule, complying to appropriate regulatory guidelines (FDA, HC, EU) / specifications and internal procedures. Provides leadership in strategy and administration of internal and external programs and processes related to validation activities and metrology for the SGS Life Sciences Markham. Develops calibration methods and techniques based on principles of measurement, technical analysis of measurement problems, and accuracy and precision requirements. Develops validation protocols meeting industry standards for equipment, utilities, and processes to ensure SGS LS regulatory compliance in support of client end use. Additionally, creates and revises Standard Operating Procedures (SOPs). Makes recommendations and implements new processes and improvements to validation and metrology processes based on industry trends, draft guidance documents and regulatory/client audit findings or suggestions.
- Create and review Standard Operating Procedures, equipment records and qualification records
- Work with support departments to obtain user requirements for equipment/utility, assist in the vendor review, instrument demonstrations/evaluations and final vendor selection process
- Manage the purchase, installation, and qualification activities for new and relocated equipment/utilities
- Monitor the equipment utilization at Markham Site to move equipment in and out of service to minimize costs and maximize availability
- Work collaboratively with lab operations and IT to develop process validation protocols
- Implement and manage the Master Equipment List
- Responsible for hands-on calibration, supervisory functions, maintenance, troubleshooting, conducting investigations and repair on a variety of equipment/utilities in such a manner to have mínimal interruptions within the testing schedule
- Manages the identification, purchase, scheduling and administration of appropriate service contracts and calibration vendors.
- Responsible for determining the need for, identifying, contracting, and managing the efforts of outside consultants and contractors
- Manage the development and implementation of a validation maintenance program which periodically reviews the status of validated systems, feedback from audits, regulatory trends & guidance documents
- Manage the development, implementation, and maintenance of equipment preventative maintenance/calibration program to ensure availability for use
- Manage the development and execution of validation protocols for all utilities, equipment (including laboratory equipment), and systems including computer systems involved in regulatory processes.
- Support activities for the retirement/re-designation of GMP equipment/utilities
- Create and revise preventive maintenance, operational and calibration procedures for equipment/utilities throughout the facility
- Provides technical expertise and training based on industry best practices to department and supporting departments, as applicable
- Contributes to the identification and procurement of appropriate test, service, and safety equipment, as well as spare parts and materials for proper maintenance, operation and cleaning for equipment/utilities throughout the facility
- Define and optimize the overall validation strategies, policies, and programs. Programs to include change control as developed by the QA department. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations
- Generate performance metrics associated with departmental work rates
- Determines project resource requirements for metrology / validation including capacity and capability. Where required assess, appoint, control and direct specific Contractors
- Maintain NIST certified reference standards / equipment in good order
- Maintain equipment LIMS database, calibration and preventive maintenance schedule;
- Ensure all calibration/ maintenance records appropriately for easier access and tracking at safe location to prevent loss and misuse while in possession Qualify/maintain/calibrate environmental chambers.
- Monitor MIRADOR Environmental Monitoring System and chambers during working hours and off work hours as assigned.
- Review Change Controls, investigations, incidents, RCAs, etc. within the metrology group
**Qualifications**:
- ** Education**: Bachelor of Science degree in Chemistry and or in Biological
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