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C&Q Lead - Syringe Filling - Pharmaceutical

  1. East
  1. Contract
  1. Commisions, Qualification and Validation
Date Posted25 Sep 2020

This vacancy has now expired

C&Q Lead - Filling line - Pharma - 11 months +

Experienced C&Q Lead required for a large scale expansion project.

We need an experienced C&Q Engineer with strong technical knowledge of sterile filling equipment to  oversee the commissioning & qualification  

Role &  responsibilities; 

  • Liaise with Suite Lead on all C&Q Activities
  • Lead the Suites C&Q activities, managing the Suite C&Q resources
  • Liaise with the various stakeholders on the Project C&Q team and the overall project
  • Participation in C&Q activities
  • Review and Input into technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix)
  • Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
Skills & experience required:
  • Experience of leading C&Q activities on multiply equipment packages
  • Sterile Filling C&Q Equipment Experience
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
  • Strong interpersonal and communication skills (verbal/written)
  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within the Pharmaceutical industry.
  • Technical knowledge of Sterile Filling equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.

Call me for more information on this vacancy.

The candidate must have the rights to work in the location stated in the job advert.

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