Commissioning Qualification Validation Lead

CQV PQ Lead - Pharmaceuticals - North Carolina - 12-Month Contract

Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV PQ Lead 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.


Main Responsibilities;

• Lead PQ conversations for CQV but including all necessary functions such as, but not limited to operations, QA, QC, process support, supply chain, etc
• Liaise with the operational readiness team to build the connection and define the handover from PQ to operations
• Build a strategy for how PQ will be executed at the site
• Work with PQ team at sister site in Denmark to clone where possible from SOPs, methods, etc. and develop a plan for localization of these in Holly Springs
• Define roles and responsibilities during PQ and gain alignment from supporting teams
• Define key milestones for PQ and develop a timeline for execution
• Work with project controls to ensure PQ milestones are appropriately reflected in the schedule
• Develop a communication strategy to ensure the site is informed about PQ and work with the head of CQV to launch
• Work with project managers to develop tracking tools and visibility to PQ activities
• Ensure our plan aligns with all necessary regulations and will support successful qualification and future site regulatory inspections
• Identify all necessary SOPs and need by dates and work with owning functions to ensure delivery
• Work in partnership with QC teams to determine the appropriate EMPQ/UMPQ strategies
• Work in partnership with the Supply Chain teams to develop a material resourcing and storage strategy to support PQ activities
• Develop a strategy for ensuring training of personnel ahead of executing PQ on site
• Work with the CQV leads, REs, and QA on the implementation of the PQ strategy in their respective areas
• Develop a high level documentation plan and work with the Kneat leads to ensure templates are ready for execution of these documents

Experience and contacts;

• Minimum 15 years Project coordination experience on Large Scale Projects
• Minimum 15 years PQ experience
• Experience with liaising with other departments and building PMs/leads, ensuring streamlined FAT deliverables for all buildings.
• Technical understanding with an ability to create a vision and communicate it to others effectively
• Experience with complex projects and working in or around operating facilities.
• Ability to keep work pace and meet deadlines. Good organizing and planning skills.
• Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
• Proven success working well in a team environment with flexibility to react to changing business needs.
• Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
• Computer skills (Primavera, Spreadsheets, Word Processing, Visio, Microsoft Project)

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

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