Lead Investigator

PharmEng Technology is currently seeking a Lead Investigator for a project in Canada. The position is available immediately conditional of a successful interview
Job Description:
·         Develop an investigation strategy in collaboration with Production, Quality Operations, SMEs.
·         Follow the Root Cause Analysis Methodology and select appropriate investigational tools to determine the true root cause and address recurrence.
·         Identify expertise required for the investigation (QC, QOVS, QOSA, MTech, Technical Services).
·         Develop appropriate CAPAs to address the true root cause in collaboration with platform management and other stakeholders.
·         Responsible to draft clear, concise and comprehensive investigation reports.
·         Manage the deviation review process and ensure the deviation is closed according to targeted timelines.
·         Follow the Deviation Review Board and Material Review Board Governance for escalated decision making.
·         Present and defend investigations in Regulatory inspections and other audits.
Job Requirements:
·         Preferred MSc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science, plus a minimum of 4 years of previous relevant experience in Commercial Manufacturing, Manufacturing
·         Technology, Quality Operations or similar role.
·         High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
·         Experience in regulatory inspections
·         Good problem solving skills and documentation skills
·         Must possess excellent communication and organization skills.
·         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

Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted
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