Senior Calibration Chemist

2 months ago

Toronto, Canada Teva Pharmaceuticals Full time

The opportunity

Senior Calibration Chemist

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

How you’ll spend your day

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

Your experience and qualifications

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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