Operations Compliance Specialist - Shanbally, Ringaskiddy, Cork
(12 Month Contract) Onsite Role
The Role:
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.
• 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.
• Strong verbal, written and oral communication skills.
• Able to work independently and be flexible to changing priorities
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