Cell and Gene Therapy

October 9, 2020

CellChain Change Control Leadership & Management

Services Scope

  • Manage the CellChain Change Control Program for all internal user stakeholders (QA/QP, Supply Chain, Manufacturing and CMOs).
  • Communicate in a timely manner, pending Changes, the scope and user impact.
  • Facilitate activities associated to Change Control Requests for the team and global users as manager to ensure CRs progress through the life-cycle. 
  • Raise Deviations , initiate and manage CAPAs as required.
  • Raise Deviations in , initiate and manage CAPAs as required.
  • Provide support and lead the activities associated with the backlog elimination, including monitoring of CRs, assigning follow up activities. 
  • Provide on-going training and guidance to all business users on Change Control aspects. 
  • Provide support and assistance to the team in creation, evaluation, approval and implementation of the CRs.
  • Provide impact analysis guidance to all impacted users. 
  • Coordinate evaluations, approval, implementations of the CRs generated changes that impact the global user community.
  • Attend and Support Site CC meetings (committee and ad-hoc) and support the committee for CR closures/cancellations at impacted manufacturing sites. 
  • Provide additional change control support such as APR/PQR; 
  • Support product launches/transfers from both, CR aspects. 
  • Participate in the various departmental project teams. Facilitate activities associated to Change Control Requests process for the team and users/stakeholders as coordinator to ensure progress of the CRs through the life-cycle

You May Also Like…

AHK Malaysia

AHK Malaysia

Over 60% of the global population is located in the APAC region, which is emerging as a considerable commercial...

Vision talk with Daniel Eisenhut:

Vision talk with Daniel Eisenhut:

VISIONTALK with Magdalena Kurpierz CEO of @KVALITOCONSULTING We talked about "just doing the work" and how Covid can...