Lead Investigator

PharmEng is now hiring a lead Investigator in Toronto, Ontario 
 
Job Description/ Duties: 
 
  • Collaborating with QO, SME and LI from other departments as required, determine the scope of the investigation.
  • Develops an investigation strategy, with assistance of the above, as required.
  • Determines appropriate analytical tools, process walks and reviews or analyses  required to determine root cause or identify all the possible root causes
  • Identifies expertise required for the investigation
  • Identify, co-ordinate and manage contributions from other departments
  • Participate in FFaST and Performance centre (PC) Action planning teams to ensure and follow planning and execution of investigation
  • Works with the QO Departments (sterility assurance, shop floor, validation) and collects data and writes/reviews drafts for non-conformance reports.  Review/provide guidance in preparation of reports prepared by technical staff.
  • Support Manufacturing investigations associated with complaints and OOS
  • Support investigations in other platforms as required.
  • Support investigations of non-conformances and development of templates as required. 
  • Extensive knowledge of aseptic filling operations, visual inspection, labelling and packaging in a pharmaceutical environment
Develop and presents risk assessments
  • Working with SMEs and appropriate QO experts, develop assessment of risk to product, process and other stages               
  • Present to Material Review Board as required
 
Develop appropriate corrective and preventive actions
  • In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause.
  • Creates and manages associated Change Controls and CAPAs
  • Identify recurrent issues or themes and develop improvement plan with area management or other stakeholders
  • Work with FFaST, F&P production team and performances centre action planning teams to ensure actions are assigned to the appropriate departments /individuals and followed up on.
  • Review notations and minor non-conformances
  • Work with the Platform Leaders and Industrial Excellence to identify and develop process improvements to remediate risks, improve investigations or avoid future non-conformances
Training
·         Review and verify training records for investigation
·         Complete self-training on time as assigned.
 
Write associated documentation and manage timelines
  • Responsible for the investigation report or manufacturing investigation report.
  • May delegate document or report drafting to appropriate involved individuals such as platform staff, SME’s etc.
  • Determines when investigations are complete and prepares the report for review and approval.
  • Manages the deviation/ investigation review process and ensures the Deviation event  is closed according to targeted timelines
  • Proactively manages dates by providing justification for extending closure dates of investigation to QO.
  • Develop and issue F&P NC status reports.
Present and defend investigation in regulatory inspections and other reviews

Requirements: 
Education/Certifications
·         Bachelor’s degree in Applied Science or Engineering, or
·         Bachelor’s Science degree in relevant major with appropriate experience
Experience
  • Experience in Pharmaceutical Manufacturing/Manufacturing Technology/Quality Operations, Engineering/Maintenance or similar role
  •   High level of  knowledge of cGMP in pharmaceuticals/biological
  •       Good problem solving skills and documentation skills
  •    Must possess excellent communication and organizational skill
  •     Excellent technical writing skills
  • Six sigma or other root cause training and experience
  • Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint
  • Working knowledge of HSE and Quality Systems
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