Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance including but not limited to the following main areas of responsibility of this role, which are as follows: Document Management Manage the authoring & drafting of all types of Manufacturing Operations documentation.Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.Specifications & associated forms in conjunction with the various departmental subject matter experts (SME) Support document updates and manage timelines for cross functional Projects.Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.Organise & Facilitate Document Round Table meetings with cross functional teams as required Mange and build Quality Veeva QMS metrics for Manufacturing Operations Coach & Train colleagues in Documentation System & GDP queries Support manufacturing operations on meeting deadlines on Veeva QMS records Update compliance procedures and processes.Compliance Tasks Generate Reports/Metrics & analyze trends as required including but not limited to: Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics.Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.Train and perform Area Self Inspections & Generate ASI schedule.Train Manufacturing colleagues in GDP/GMP Management of Veeva paper Binders Continuous monitoring of Compliance in Manufacturing.Facilitate all internal and external Inspections.Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations.Additional tasks: Collaborating with Global colleagues (as required) including but not limited to: Supplier Change Notifications, EDMS & Managerial Data Management Management of Job Descriptions & New Hire Checklist and Assigning Lockers.Be proactive & collaborative in troubleshooting & resolving issues with documentation, training & systems collaborating with different departments across the site.Engage in Continuous Improvement Initiatives Manage compliance projects and Inspection readiness updates.Apply aligned Operations Compliance Specialist role skills across Drug Substance, Drug Product and Packaging.Requirements 2+ years experience in technical writing and compliance Proficient in data analytics, data visualization Working knowledge in Regulations, GMP, GDP 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
xsokbrcStrong verbal, written and oral communication skills.