Regulatory Compliance Officer

6 days ago


Nottingham, Nottingham, United Kingdom X4 Life Sciences Full time £45,000 - £55,000

About the Role

X4 Life Sciences is seeking a highly skilled Quality Engineer to join their Nottingham-based team. This is an exciting opportunity to own the quality and manufacturing process for their UK site, which is currently undergoing clinical trials.

Key Responsibilities

  • Conduct raw material inspections and incoming goods checks to ensure compliance with regulatory requirements.
  • Maintain inventory of consumables, raw materials, and finished product to optimize production efficiency.
  • Perform calibration and maintenance of manufacturing and test equipment to ensure accuracy and reliability.
  • Support lean manufacturing activities and process improvements to enhance productivity and quality.
  • Conduct pre, in-process, and post-manufacturing checks to ensure process suitability and identify areas for improvement.
  • Develop and maintain site validation master plans to ensure compliance with regulatory requirements.
  • Support process and equipment validations to ensure accuracy and reliability.
  • Act as primary contact for raw material suppliers to ensure timely delivery and quality of materials.
  • Maintain batch manufacturing records and associated production records to ensure compliance with regulatory requirements.

Requirements

The ideal candidate will have a strong background in quality engineering and manufacturing process control. They will be able to work independently and as part of a team to drive process improvements and ensure compliance with regulatory requirements.



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