Commissioning/Qualification Project Lead

Location: Morris Plains, NJ

Job Description

Our client, a leader in the pharmaceutical industry, is looking for a Commissioning/ Qualification Project lead to join their dynamic team. This role will lead the overall execution of Commissioning and Qualification project regarding scheduling, monitoring, execution and closure according to GMP, Regulatory and safety requirements.

General Responsibilities

  • Collaborates with Clients Qualification team representative on project timelines, deliverables, activities and issue resolution.
  • Effectively manage complex Commissioning and Qualification projects to ensure adherence with project timelines and budgets
  • Takes a leadership role in managing/coordinating the project Commissioning and Qualification project activities
  • Prepares Commissioning/Qualification Project Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents according to Clients SOPs and requirements
  • Establish and maintains detailed project plans
  • Supervises/coordinates work of contractors in the execution of project activities.
  • Establish and maintain communication plan within the project qualification team (meetings, minutes, maintain project action items) and provides routine project updates to Clients Qualification team representative.
  • Coordinates interfaces and activities with other departments
  • Writes, reviews or revises Standard Operating Procedures related to Engineering Commissioning and Qualification systems and Processes
  • Leads the Commissioning and Qualification project teams. Delegate’s responsibility to project team contractors.
  • Coordinate external contracted project resources and third parties/vendors for the flawless execution of Commissioning and Qualification projects activities.
  • Manages project risks and strategic influencing to maintain project timelines.
  • Ensures compliance with client and Regulatory regulations for Commissioning and Qualification.
  • Create and maintain comprehensive project documentation.
  • Ensures the project turnover documentation is supplied and organized.
Requirements
  • Candidates should possess strong background in the Qualification and Commissioning of classified Clean Rooms and associated equipment/utilities.
  • Candidates should have recent hands on experience with authoring Qualification Plans, Qualification/Commissioning protocols and protocol executions.
  • Project management and Team leader experience is required with the scope of Qualification/Commissioning activities.
  • Experience with qualification of customized equipment is preferred.


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