Operations Compliance Specialist

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