12 Month Contract
The 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.
• 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.
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.
• Train and perform Area Self Inspections & Generate ASI schedule.
• Train Manufacturing colleagues in GDP/GMP
• Management of Veeva paper Binders
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.