Responsibilities
This role will manage CMO activities including all the documentation requirements of Packaging operations.
Management (development, review, and approval) of new and modifications to technical profile drawings and purchasing/release specifications is necessary.
Ability to multi-task and achieve tactical deliverables with little to no supervision while understanding strategic impact training.
Lead or own change control, non-conformances, and CAPA activities working with Quality and Global Labeling Operations.
Profile
Bachelor’s Degree in an engineering-related field; Packaging Engineers preferred.
Solid pharmaceutical experience (or equivalent).
Knowledge of electronic documentation systems (necessary: Trackwise).
Strong knowledge of cGMP documentation requirements and strong technical, interpersonal, communication, and leadership skills.
Knowledge and experience in using Trackwise is necessary.
Knowledge of developing and experience in qualifying packaging components on packaging equipment is necessary.
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