Beschreibung
Major Activities:1. Support Change Control Coordinator onsite
2. To lead the on-site and inter-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities, cGMP's, regulatory requirements.
3. To establish and support on site project teams in order to ensure project management ac-cording to the agreed strategy and timelines.
4. To ensure efficient, timely and clear communication to all involved partners (on-site and off-site incl. to global product lifecycle leader and REG CMC) as required for flawless project execution in collaboration with project leader
5. To communicate project progress and deviations as appropriate. To elaborate risk mitiga-tion plans as appropriate in collaboration with project leader
6. To solicit input from site functions and to ensure that site specific information is made available in global projects and in relevant databases
7. To ensure timely delivery of complete and consistent source data to TRD REG CMC.
8. To co-ordinate and provide timely review (on-site) of CMC documentation
9. To ensure that projects are realized/implemented without stock-outs. To ensure that write-off costs are kept to a minimum
10. To support process experts in evaluation, planning and execution for main and sub pro-cesses (e.g. CAR, capacity planning, resources, etc.)
11. To support training and development of on-site personnel with regards to skills and capa-bilities required for change project management
Michael Bailey International is acting as an Employment Business in relation to this vacancy.