Teva Senior Calibration Chemist 

Canada, Ontario, Toronto 

632889071

Under the direction of the functional leader performs various activities to maintain all analytical instrumentation and ensure their accuracy and GMP compliance.

• Perform precision repairs on complex analytical instruments utilized in the Laboratory.
• Coordinate external service technicians as required.
• Ensure adequate supply parts are available to ensure testing proceeds with minimal interruption.
• Perform requalification after repair (as needed)
• Assist onsite Metrology Group with the above duties.
• Perform preventative maintenance and Qualification on analytical instruments to minimize unexpected downtime.
• Follow Preventative Maintenance procedures as described in the respective SOP.
• Use due diligence to monitor and replace/repair any other parts where which may hinder the proper function of the instrument.
• Ensure adequate supply parts are available to ensure testing proceeds with minimal interruption.
• Assist onsite Metrology Group with the above duties.
• Audit PM/Qualification documents produced by onsite metrology group and track RFT statistics to develop improvement strategies.
• Monitor costs of maintaining instrumentation and provide feedback to promote and implement cost effective procedures while maintaining GMP compliance.
• Monitor repair, service and maintenance costs of all analytical instrument
• Implement cost saving measures or procedures while maintaining GMP compliance.
• Create and maintain SOPs for the qualification of analytical instruments and ensure qualification intervals are adhered to and documented.
• Ensure qualification intervals are adhered to and documented as per SOP
• Maintain the LIMS database to track all instrument PM and qualification intervals.
• Review and revise SOPs to keep them up to date with current practices.
• Review laboratory testing needs when determining qualification procedures.
• Fully implement new technology or instrumentation in the laboratory to ensure GMP compliance.
• Review manufacturer documents and instrument manuals to determine PM and qualification procedures.
• Maintain communication with the manufacturer/vendor to obtain a full understanding of the functionality of the technology
• Create SOPs for the PM/Qualification of new technology.
• Liaise with IT Department, Engineering Department, Maintenance Department, Lab Management, Manufacturer/Vendor, EH&S and other contacts to ensure all facets of implementation are performed.
• Coordinate and follow up on any tasks which may hinder/delay the implementation of the new technology/instrumentation
• Lead the onsite Metrology Group by encouraging critical thinking and adhering to assigned timelines.
• Assist direct supervisor with the coordination and implementation of all or part of unique projects in the QC Laboratory
• Assist direct supervisor with monitoring the Quality, RFT, Compliance and Process Confirmation of on site Metrology Group and actively promote quality improvements
• Liaise with IT Department, Engineering Department, Maintenance Department, Lab Management, Manufacturer/Vendor, EH&S and other contacts to ensure all facets of implementation are performed.
• Coordinate and follow up on any tasks which may hinder/delay the implementation of the project
• Other duties as assigned

• University Degree in Chemistry, Chem. Eng., or other related discipline
• 5+ years of relevant experience.
• Advanced technical knowledge and experience with a wide variety of analytical instrumentation employed in a pharmaceutical laboratory
• Progressive experience in laboratory instrument trouble shooting, repair, maintenance and qualification procedures
• Exhibit good written and verbal communication skills in order to:
• Interact with a variety of Teva management to establish and maintain important business relationships
• Provide technical training, guidance and advice to others on laboratory instrumentation techniques and operation.
• Knowledge of SAP, LabWare LIMS, Document Management System, MS Office, Lotus Notes, Web based applications suitable for QC Lab environment.
• Analytical methods and techniques common to QC Lab
• GMP, cGMP, ICH and other requirements as it relates to instrument qualification and validation.
• Budgets, spending requirements, regulations and limitations
• Key measurements to support business such as customer service, cycle time, costing, etc.
• Strong organizational and time management skills
• Ability to work well under pressure in a stressful and fast paced working environment
• Required to work independently and follow through on assignments/instructions/tasks with minimal supervision/direction

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