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QA & Commercial Readiness Consultant

  1. Brussels
  1. Contract
Competitive
25614/AN
  1. Compliance / Quality Assurance
Date Posted14 Oct 2020
QA & Commercial Readiness Consultant - 6 Months - Belgium

Contract opportunity to support a rapidly growing Biotech company in expanding their Belgian facility and helping them with Commercial Readiness.

Initially, your responsibilities will include:
  • Ensure the facilitation of the preparation for the site readiness to host Belgium Health Authorities.
  • Assess the state of readiness versus latest previous observations and remediations stated
  • Ensure and drive the completion of open Corrective and Preventive Actions related to inspection readiness
  • Define and Coach the Team hosting the inspection for good behaviour and efficiency
  • Report to the Site Quality Assurance Manager of progress and difficulties
  • Ensure back room support to prepare answers to inspectors during the inspection
  • Support the transition of the Site’s Quality Compliance Elevation
  • Coach the different subject matters Experts on Quality requirements for commercial readiness
  • Coach and drive the actors for the improvement of Deviation, CAPA and Change Control processes
  • Ensure the improvements of the Deviation, CAPA and Change Control processes according to Catalent KPI and targets
  • Report to the Site Quality Director of progress and difficulties
 
Profile and background Expected :
  • Expert in quality management, Management of teams, mentoring and Coaching of people. (10 years min)
  • Capable of interacting with and providing support to departments interfacing with QA, such as QC, Production, R&.
  • Former QA Director or Manager, QP could be a plus
  • Experiences in QC and QA
  • Knowledge in aseptic environment, cell therapies, and Clinical processes.
  • Experience in Change and continuous improvement management
If you think this role fits your skillset and experience, please apply now!

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

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