Job Description
Job Title: Senior Document Control Specialist
Job Description
The Senior Document Control Specialist maintains quality documentation and manages site-wide document control systems to ensure full adherence to Current Good Manufacturing Practices (cGMP) and compliance with regulatory standards, including USFDA Title 21 CFR Parts 210 and 211 and Q7 Good Manufacturing Practice guidance for active pharmaceutical ingredients. This role supports manufacturing and quality operations by ensuring that all controlled documents and records are accurate, current, traceable, and readily accessible for internal use and regulatory inspections.
Responsibilities
+ Manage document control systems and processes to ensure their integrity and compliance with cGMP regulations and applicable regulatory standards.
+ Maintain master indices and tracking for standard operating procedures, deviation reports, change control reports, technical reports, protocols, batch record files, valid...
Job Description
The Senior Document Control Specialist maintains quality documentation and manages site-wide document control systems to ensure full adherence to Current Good Manufacturing Practices (cGMP) and compliance with regulatory standards, including USFDA Title 21 CFR Parts 210 and 211 and Q7 Good Manufacturing Practice guidance for active pharmaceutical ingredients. This role supports manufacturing and quality operations by ensuring that all controlled documents and records are accurate, current, traceable, and readily accessible for internal use and regulatory inspections.
Responsibilities
+ Manage document control systems and processes to ensure their integrity and compliance with cGMP regulations and applicable regulatory standards.
+ Maintain master indices and tracking for standard operating procedures, deviation reports, change control reports, technical reports, protocols, batch record files, valid...
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