Job Description:
As a Compliance Specialist, you will be responsible for managing the authoring and drafting of all types of manufacturing operations documentation. This includes specifications and associated forms in conjunction with various departmental subject matter experts (SMEs). You will also support document updates and manage timelines for cross-functional projects.
Key Responsibilities:
* Manage the authoring and drafting 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 and approval of documents
* Organize and facilitate document round table meetings with cross-functional teams as required
* Mange and build Quality Veeva QMS metrics for Manufacturing Operations
* Coach and train colleagues in Documentation System and GDP queries
Requirements:
* Working knowledge in regulations, GMP, and GDP
* 2+ years working within a regulated healthcare industry including a role in capacity of quality and compliance
* Experience using Veeva is essential
About Us:
We are a leading provider of contract services to the biopharmaceutical industry. Our team is dedicated to delivering high-quality solutions to our clients.