The Equipment Management Associates will perform all activities with regards the GxP compliance of all CMC equipment.
The individual has a responsibility to work with BioPharmCMC sections and BioPharmCMC management etc where appropriate to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GLP and or GCP / and or GMP) specified in the study plans, protocols, or work agreements governing the work in which they are involved.
Reports to Choose from list on a daily basis (a permanent change of supervisor will be documented in training records) and to the relevant QC SCi on a study specific basis.
The post holder will ensure adherence to the BioPharmCMC SOPs and will be responsible for completion of all relevant documentation.
1) Adhere to and/or complete all equipment documentation. This includes, but is not limited to:
2) Coordinate with in house or vendor maintenance and qualification activities:
3) Where required arrange for the installation and set-up of new equipment.
4) Complete GMP quality records to an appropriate standard related to equipment failures and changes:
5) Compose documents from concept
6) Serve as the subject matter expert (SME) and main point of contact for equipment / process
7) Arrange purchases for GMP EM Team or Operations
8) Approve documentation completed by other associates with instrument knowledge confidence
9) Engage in improvement initiatives towards a singular process for all EM processes and documents.
10) Assist Global Business Technologies (GBT) and other areas of Global Laboratory Systems to assist in computer system validation (CSV) activities:
11) Serve as SME for complex analytical instrumentation (e.g. HPLC, UPLC, Mass Spec)
12) Coordinate large project scopes to ensure proper execution and timely completion
13) Prioritize GMP EM Team function
The post holder should typically have: