GMP Compliance Specialist

7 days ago


Cambridge, Ontario, Canada Septodont Full time
About the Role

We are seeking a Production Support Manager to lead our production quality processes, including Deviations and investigations, Production Training, Batch Documentation review, Tech Writing, and acting as an internal liaison while complying with GMP regulations.

Responsibilities:
  • Manage production quality processes, including Investigation Programs, Corrective Action/Preventative Action Programs (CAPA), and Oversee and execute quality system processes and other relevant documentation as outlined in the Quality Assurance Program.
  • Develop and implement actions and initiatives to achieve set quality, safety, and production targets, responsible for administration and reporting for OEE Program, and tracking and reporting of production metrics such as output, scrap, labor hours, to forecast/budget.
  • Support Continuous Improvement specialist on CI projects, such as cost savings, training initiatives, and OEE Improvements, in support of Manufacturing Excellence Program and annual strategic objectives.
  • Manage the development and review of related production SOPs, Batch documents/Batch Records Review, and other GMP documents (Tech Writing).
  • Collaborate with cross-functional internal and external Technology experts to implement new initiatives for the Production floor to improve operational efficiencies.
Requirements:
  • Bachelor's degree in a related discipline such as Science or Engineering.
  • Minimum 5 years of related experience in pharmaceutical manufacturing with a combined minimum of 2 years management experience.
  • Proven leadership in coaching teams, resolving conflicts, and driving cross-functional collaboration to meet organizational goals.
  • Demonstrated capabilities in leading diverse teams with both direct labor and technical professionals.
  • Successful execution of Continuous Improvement projects, streamlining processes, enhancing efficiency, using Lean and Six Sigma principles.
  • Expertise in investigations and root cause analysis, resolving quality and compliance issues with effective corrective actions.


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