Job Position: Senior Chemist, GTO Job
Job Description: Bahrain – . Requisition ID: PRO016269 The GTO Senior Chemist supports the Lead Engineer/Chemist in introducing new products to the site, providing technical expertise on the manufacture of all drug products on site and transferring drug products to other facilities. In collaboration with supporting functional groups, the GTO Sr Chemist provides technical guidance on deviations, investigations and customer complaints. The GTO Sr. Chemist supports continuous process improvement activities to enhance site performance metrics and contributes to global technical networks to share site experiences and expand on personal and site expertise. Supports new product introductions to the site by assisting with process and equipment comparisons, new raw material introduction, development studies, cleaning processes development and validation and process fit and gap analysis. * Supports filing activities by assisting with process qualification activities, equipment qualification and cleaning validation. Expected to have a working knowledge of QMS chapter 13, 17, 25 and 35 and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing Supports routine supply manufacture by providing on going technical support to the IPT and proactively monitoring the performance of equipment/module(s) or unit operation(s) during manufacturing and cleaning. Responds to shifts and trends in performance appropriately and based on the data identifies opportunities for improvement. * The GTO Sr. Chemist is the change owner for process Global Change Management (GCM) change controls. * Provides technical expertise related to Process Chemistry in manufacturing/cleaning processes in response to deviations to understand and eliminate the root cause(s). Performs lab front runs and analytical testing to provide supporting data related to equipment and manufacturing/cleaning processes in response to deviations to understand and el…see more details
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