C&Q Lead – Vega Baja, PR

Must have pharmaceutical manufacturing experience.

Project Duration – 18 months approximately.

Related Experience: 15+ Years

Education: Bachelor’s Degree in Science or Engineering 

Work Description: 

  • C&Q activities leadership, such as coordination, scheduling and follow-up activities with system users, supporters, SMEs, and others.
  • Develop with the Sr Verification Engineer the project C&Q strategy as per site procedures.
  • Generate project related Change Controls and closure.
  • Generate Project C&Q Plan (PCQP).
  • Manage site electronic platforms as per role requirements (PDOCs & QTS).
  • C&Q knowledge of requirements on manufacturing process equipment, automation, facilities, and utility systems.
  • Able to discuss issues with QA, EHS, Manufacturing and Technical Services to reach sensible agreement.
  • Provide technical direction to all contractors/resources supporting C&Q activities. 
  • Strong interpersonal, teamwork and problem-solving skills.
  • Coordination of C&Q documentation revision, organization, approval, and filing.
  • Be active in the resolution of problems or deviations found during the qualification activities.
  • Determine interactions between qualification of systems.  
  • Fully Bilingual: verbal and written.