Senior Calibration Chemist

3 weeks ago

Toronto, Ontario, Canada Teva Canada Full time

We're seeking a Senior Calibration Chemist to maintain analytical instrumentation, ensuring accuracy and compliance with GMP.

Job Description

As a Senior Calibration Chemist, you will perform precision repairs on complex analytical instruments, coordinate external service technicians, and ensure adequate supply parts are available. You will also perform requalification after repair, assist onsite Metrology Group, and perform preventative maintenance and qualification on analytical instruments. Additionally, you will audit PM/qualification documents, track RFT statistics, and monitor costs of maintaining instrumentation. You will implement cost-saving measures while maintaining GMP compliance, create and maintain SOPs for instrument qualification, and ensure qualification intervals are adhered to and documented.

Responsibilities
  • Perform precision repairs on complex analytical instruments
  • Coordinate external service technicians as required
  • Ensure adequate supply parts are available to minimize testing interruptions
  • Perform requalification after repair (as needed)
  • Assist onsite Metrology Group with the above duties
  • Perform preventative maintenance and qualification on analytical instruments
  • Follow Preventative Maintenance procedures as described in the respective SOP
  • Use due diligence to monitor and replace/repair parts that may hinder instrument function
  • Assist onsite Metrology Group with the above duties
  • Audit PM/qualification documents produced by onsite metrology group and track RFT statistics
  • Monitor costs of maintaining instrumentation and provide feedback to promote cost-effective procedures
  • Implement cost-saving measures or procedures while maintaining GMP compliance
  • Create and maintain SOPs for instrument qualification 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 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 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 that 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 onsite 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 that may hinder/delay the implementation of the project
  • Other duties as assigned
Requirements
  • 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
  • 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

As a Senior Calibration Chemist, you will be part of a team that works with the world's leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization's Essential Medicines List.

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