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
