Analytical Method Validation

PharmEng Technology is currently seeking an Analytical Method Validation Consultant to join our team for projects in ON, Canada

Job Description:
  •          Preparation of an Analytical method validation master plan
  •          Preparation of an instrument qualification master plan
  •          Preparation of an analytical method validation SOP
  •          Development of training material for AMV (optional)
  •          Review of existing AMV template; update and implementation
  •          Analytical method validation template
  •          Instrumentation qualification procedure
  •          Instrumentation qualification should include Part 11 compliance, lab system validation / no LIMS
  •          Gap assessment of existing lab qualification documentation (180 systems
  •           Traceability matrix requirements. Requalification – remediation of existing instrument qualification package
  •          Development of AMV protocols – instrument analysis, bioassays for biologics
  •          . Support coordination of vendor executed requalification with GCBT team.
  • Operation and use of multiple analytical instruments (i.e., LC, GC, UPLC, GFAA, ICP, UPLC-MS, ICP-MS)
  • Collaboration with global labs to align methods
  • Performs all necessary method validation documentation (protocols, methods, SOPs, reports)
  • Applies strong analytical and problem solving skills to quality control analyses
  • Assures laboratory operation is aligned with applicable regulations, GMPs, and MJN Quality SOPs by actively supporting policies and procedures.
  • Plans and prioritizes work according to the daily needs of multiple methods to support timely validations
  • Proactively suggests improvements to work approaches and assumes responsibility to ensure work is completed..
  • Works proactively to streamline processes, work streams and improve efficiencies. Timely report progress through directed metrics
Job Requirements:
  • B.S. in Chemistry or other relevant science degree is required. Advanced degree preferred. 
  • A minimum of 3 years experience in an analytical laboratory required.  
  • Technical/theoretical expertise and experience with multiple modern analytical techniques (e.g. LC, GC, UPLC-MS, GFAA, ICP) is required. 
  • Experience with method validation work is required. 
  • Excellent technical writing and communication skills strongly desired. 
  • Experience providing product and/or process support in a pharmaceutical manufacturing environment is strongly desired. 
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