The Perrigo Company in Allegan is seeking an Informics Scientist in Research and Development. This is a full-time position.
The person who is hired for this position serves as the business lead for informatics projects and improvement initiatives by providing technical expertise on informatics related items across GSA-CHC R&D.
He or she will manage all aspects of the informatics lifecycle to improve efficiency and maximize alignment between GSA-CHC R&D sites and with IT&S.
Demonstrated ability to effectively manage the life-cycle of informatics projects of varying complexity and cross-departmental and site scope. This includes, but is not limited to, business requirement identification, vendor selection, ROI assessment, appropriation request preparation, development, validation, training, deployment, continuous improvement, gap identification/remediation and application retirement.
Demonstrated ability to create a wide variety of technical documentation, including but not limited to functional requirements, design specifications, IQ/OQ/PQ protocols, traceability matrices, User and Administrative process maps, standard operating procedures, and standard work instructions.
Demonstrated ability to develop an application knowledge base and transfer via training to end Users is required. Familiarity with IT&S Stage Gate project management methodology is preferred. Extensive functional knowledge of R&D informatics systems is preferred.
Strong leadership skills and communication skills are essential to work effectively in interdisciplinary teams and interacting with IT&S.
A thorough working knowledge of cGMP, cGLP, other US FDA regulations, and ICH guidance documents is essential. These skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 6+ years of relevant professional experience, or completion of a master degree in Chemistry or Pharmaceutical Sciences combined with 3 to 5 years of relevant professional experience in a cGMP or cGLP laboratory.
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