Job Description
Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance.
Responsibilities
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.
Manage 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 & analyse trends as required including but not limited to:
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.
Collaboration 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 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+ years 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.
Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Cork
State/Province Cork
Country Ireland
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