Alphanumeric is hiring a COMPLIANCE SPECIALIST - Computer System Validation Consultant to work remotely out of the Research Triangle Park, NC area with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Key Responsibilities:
* Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System) * Monitoring project and/or support activities to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes * Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution * Project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organisations, and Third-Party suppliers/service providers * Participating in the deployment, maintenance and inspection support of multiple global projects including responsibility, with management oversight, for the developing solutions that maintain compliance and keep validation on schedule and on budget * Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems * Provision of performance measures to drive performance and continuous improvement * Performing periodic compliance reviews of Tech systems
Job Requirements
Must be able to work W2 Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. Established in 1979 we lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs. But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!) Apply today to join our family and Make Your Mark!