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CQV Manager

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36582

This vacancy has now expired

CQV Manager - Ohio, United States - 12 Months Contract 

This is a fantastic opportunity for a  CQV Manager to join our major, global pharmaceutical client on their latest new-build project based in Ohio , this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
  • Develop the CQV strategy and organizational structure for all CQV activities for the new pharmaceutical manufacturing facility.
  • Lead and manage CQV activities for the new pharmaceutical manufacturing facility.
  • Develop and implement CQV plans, protocols, and procedures in compliance with regulatory requirements and industry standards.
  • Oversee the commissioning of equipment, systems, and utilities to ensure they are installed and functioning correctly.
  • Conduct and document commissioning tests and inspections.
  • Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, systems, and processes.
  • Ensure all qualification activities are thoroughly documented and meet regulatory requirements.
  • Lead validation activities for manufacturing processes, cleaning procedures, and computer systems.
  • Develop and execute validation protocols and reports, ensuring compliance with GMP and regulatory standards.
  • Identify potential risks and develop mitigation strategies to ensure successful CQV activities.
  • Ensure compliance with all health, safety, and environmental regulations.
  • Maintain accurate and up-to-date documentation for all CQV activities, including protocols, reports, and deviations.
  • Prepare and present progress reports and updates to project management and stakeholders.
  • Work closely with project managers, engineers, and other stakeholders to ensure seamless integration of CQV activities with overall project plans.
  • Maintain effective communication with regulatory agencies and ensure timely submission of required documentation.
  • Identify opportunities for process optimization and implement improvements to enhance efficiency and compliance.
  • Stay updated with the latest advancements in CQV practices and regulatory requirements.
 Skills and Experience:
  • BS in Engineering, Life Sciences, or a related field
  • Extensive experience in CQV management, preferably in the pharmaceutical or biotechnology sector.
  • Excellent project management and organizational skills.
  • Excellent problem-solving and analytical skills, teamwork abilities and willingness to take on responsibilities beyond the traditional construction management role.
  • Ability to read and interpret technical drawings and specifications.
  • Strong communication and interpersonal skills.
  • Proficiency in CQV software and tools including KNEAT Software.
  • Professional certification in CQV or related field is a plus.
If this role is of interest, please apply now!
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