Supervises all activities related to providing required documentation and all updates of all documentation systems. Ensures that projects are completed on schedule, following established procedures and schedules. Lead and participate on cross-divisional/functional product development, special project and training teams. Able and willing to perform all activities associated with the QA Compliance Group including word processing to support operations and other departments.
A minimum of bachelor degree in science related field. Minimum of 6-8 years of pharmaceutical industry experience is required. Experience in QA/QC is desirable. Supervisory experience preferred.
Understanding of cGMPs and regulatory requirements, company procedures and policies. Excellent interpersonal, communication and technical writing skills.
Experience leading cross-functional and cross-divisional teams.
In-depth knowledge of product/document management.
Must be capable of operating in a computing environment that consists of Windows, Microsoft Office tools, LIMS, SAP, SmartSolve.
Must be self-motivated, have good interpersonal skills and capable of analyzing and solving complex problems.
Requires excellent formal and informal communications skills.