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Performance Qualification Project Manager

  1. United States
North Carolina
  1. Permanent
Competitive
  1. CAPEX Projects
34594
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Performance Qualification Project Manager - Pharmaceuticals - North Carolina - 12-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented Performance Qualification Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Key Responsibilities:
  • Lead PQ conversations for CQV, specifically addressing mixing solutions, microbial solutions, and buffer solutions, and coordinating with operations, QA, QC, process support, supply chain, etc.
  • Liaise with the operational readiness team to define the handover process from PQ to operations, ensuring seamless integration of mixing solution, microbial solutions, and buffer solutions requirements.
  • Develop a strategy for executing PQ at the site, emphasizing mixing solution, microbial solutions, and buffer solutions, and ensuring alignment with overall project goals.
  • Collaborate with the PQ team at our sister site in Denmark to adapt SOPs, methods, etc., for localization in Holly Springs, with a specific focus on mixing solution, microbial solutions, and buffer solutions.
  • Define roles and responsibilities during PQ, including those related to mixing solution, microbial solutions, and buffer solutions, and secure alignment from supporting teams.
  • Establish key milestones and develop a timeline for PQ execution, integrating requirements for mixing solution, microbial solutions, and buffer solutions.
  • Coordinate with project controls to integrate PQ milestones into the overall project schedule, with a particular focus on timelines related to mixing solution, microbial solutions, and buffer solutions.
  • Develop a communication strategy to inform the site about PQ progress, specifically related to mixing solution, microbial solutions, and buffer solutions, and collaborate with the head of CQV for effective launch.
  • Work with project managers to create tracking tools and ensure visibility of PQ activities, focusing on tracking mixing solution, microbial solutions, and buffer solutions parameters.

Experience and Qualifications:
  • Minimum 10 years of project coordination experience on large-scale projects.
  • Minimum 10 years of PQ experience, with a strong background in mixing solution, microbial solutions, and buffer solutions.
  • Experience in liaising with various departments and building streamlined FAT deliverables for all buildings, focusing on mixing solution, microbial solutions, and buffer solutions.
  • Technical understanding with the ability to create a vision and effectively communicate it, particularly in the context of mixing solution, microbial solutions, and buffer solutions.
  • Experience with complex projects and operating facilities, specifically those involving mixing solution, microbial solutions, and buffer solutions.
  • Strong organizational and planning skills with the ability to meet deadlines, especially related to mixing solution, microbial solutions, and buffer solutions.
  • Proficiency in communication and collaboration across various levels and functions, emphasizing requirements for mixing solution, microbial solutions, and buffer solutions.

If this role is of interest to you, please apply now! 

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