Teva Analytical Development Chemist III 

Canada, Ontario, Toronto 

573032451

• Plans and performs analytical method development, validation and method transfer for various analytical techniques for physical and chemical analysis of pharmaceutical materials.
• Develops and validates, in compliance with all current SOP’s and regulatory requirements, analytical methods of limited complexity with assistance from the senior chemist.
• Prepares method validation reports summarizing analytical data in concise write-ups of high quality in a timely manner.
• Plans and fully co-ordinates most aspects of work in a logical fashion and performs in an accurate and timely manner that is cost effective.
• Displays good problem solving skills and shows innovation on an on-going basis.
• Operates and troubleshoots analytical laboratory instruments such as HPLC, UPLC, GC, Malvern Particle Size Analyzer, UV, FTIR, ICP-MS and Dissolution Apparatus.
• Displays very good written and verbal communication skills.
• Contributes to the participation of the QC support group in the Quality Control Laboratory.
• Ensures the efficient timely completion of work in accordance with the established priorities.
• Actively participates in meetings with Supervisor and peers to ensure collaboration and information is collected to make informed decisions in order to resolve issues.
• Collaborates with other QC Lab groups to help capture synergies, organize, and prioritize requirements meet established goals.
• Participates in the implementation of processes in the Quality Control Laboratory to expedite analytical testing, improve customer service, reduce operational costs and improve laboratory safety.
• Effectively communicates, exhibits the company values, maintains priorities and monitors training to ensure a high standard of performance.
• Adheres to, safe operational practices to prevent accidents and avoid danger to others in the workplace.
• Perform all test folloowing GMP regulations and health and safty princilples.
• Supporting Tech Services activities.
• Performs and if needed recommends analytical testing including dissolution, disintegration, assay, impurities and CU/BU etc., to support any formulation and process changes as well as technology transfer projects.
• Supports evaluations of the analytical data to identify and resolve product chemistry, uniformity and drug dissolution related issues.
• Provides feedback and suggestions to Tech Services.
• Performs other related duties as required.
  

Required: University Degree or College Diploma in Chemistry or related science
2+ years of experience in the related field

Solid knowledge of:

• Method validation fundamentals and requirements
• Analytical laboratory equipment common in QC Lab environment (HPLC, UPLC, GC, Dissolution, Particle Size Analyzer, UV, FTIR, and ICP-MS etc.).
• Technical requirements as per compendia (USP/NF,BP/EP), in- house methods and general QC laboratory procedures
• ICH guidelines, GMP/cGMP regulations as they apply to the laboratories.

Demonstrates good written and verbal communication skills in order to:

• Interpret analytical data and discuss the issues/problems with the manager and senior chemists if required.
• Write in a lucid format, Technical evaluation reports, validation/method transfer reports and other relevant QC documents

Knowledge of, and experience in a Quality Control Laboratory and working knowledge of GMP/cGMP as they pertain to QC laboratory unit.
Analytical methods and techniques common to QC Lab
Computer skills with proficiency in Microsoft Office and Labware LIMS, navigating online compendia publications

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