Associé, Stabilité

The Stability Associate will be responsible for initiating stability studies (annual stability program, compliance, post-approval changes, thermal and freeze / thaw cycles, Zone II and IV submissions and bulk storage duration). He / She will be responsible to create stability protocol in the stability software for any new product added in the annual program and to maintain up to date existing protocols. He / She will be responsible to follow up with departments concerned to provide necessary documents to set-up stability studies. He / She will be responsible to confirm the reception of stability samples (regular and narcotics) and to inform sampling specialist of any deviation. The incumbent will manage stability samples, the stability rooms as well as stability inventory.

RESPONSABILITIES & DUTIES :

• Start-up stability studies (annual, conformity and post approval changes programs, submission zones II and IV, freeze thaw and thermal cycles, bulk holding time)
• Create and update stability protocols in stability software
• Management of stability samples and stability rooms :
• Pull out samples for regular analysisPlace stability samples in designated stability roomSend remaining samples in destruction once stability study completedUpdate stability inventory
• All other relevant tasks

Skills, knowledge & abilities :