Stallergenes Greer

CSV Supervisor

Job Description

  • Plan, schedule, execute and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy, and re-validation of existing computerized systems.
  • Evaluate and define technical needs and make recommendations.
  • Prioritize, manage and execute multiple projects utilizing Project Management methodology.
  • Perform business development activities.
  • Directly manage assigned projects to satisfy specific project/client needs.
  • Generation/execution of System Impact and Critical Aspect Assessment impact.
  • Coordinate and interface with project managers, as well as engineering and quality assurance groups to ensure successful project execution.
  • Lead cross-functional project teams in the development of validation deliverables.
  • Review and approve validation project documentation.
  • Develop validation deliverables including master plans, protocols and summary reports, as required.
  • Support development of best practices within the validation group, based on current industry practices and guidelines.

Education Requirement

Bachelor's Degree

Experience Requirement

  • Minimum 10 years experience in a highly regulated environment: pharmaceutical, biotech or related industry
  • 2 to 3 years experience in project management (preferred)
  • Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
  • Familiar with off-the-shelf, configurable and custom developed applications
  • Knowledge of validation deliverables associated with each step of the computer system life cycle
  • Experience with various technologies and automated systems used in the pharmaceutical industry
  • Information Management, Business System (ERP), PLC or SCADA, DCS, Process Control, laboratory instrumentation, data archive/historian, etc
  • Experience in process automation an asset

 

Additional Skills

  • 1-2 years experience with JD Edwards One World is desired
  • 5 years experience in a managerial/supervisory role in the pharmaceutical industry

To apply for this position, please visit your local Employment Security Commission office. You may also direct questions to .(JavaScript must be enabled to view this email address).

 

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