Pros: flexible work hours
Cons: benefits being cut back, frequent sr. staff changes creating confusion as to what direction the company is taking, lack of commnication
My typical day involves working with Operations directors & staff to assist in maintaining GxP in their operations. I am the QMS software administrator, currently developing the next phase roll-out of Quality Processes. i am the liasion between NYBC & the software vendor. I assist in development of workflows, entering in the configuration changes, creating validation plans & endure there are executed appropriately.
I also back up the Director of Regulatory Affairs, in the reporting of BPDR, ensuring licenses and Permits are up to date.
I also assist the internal audit team as needed during internal audits.
I enjoy working on different projects, interacting with operational staff to better understand their processes and needs, and ensuring the company is in compliance with all regulations.
The most difficult (I would rather say tedious) is validation - process validation, software configuration change validation, etc.