Job Description
Document Control Specialist (cGMP Environment)
Overview:
We are seeking a detail-oriented Document Control Specialist responsible for maintaining quality documentation and managing document control systems. This role ensures compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory standards, including USFDA 21 CFR Parts 210 and 211, as well as ICH Q7 guidelines for Active Pharmaceutical Ingredients (API).
Key Responsibilities:
+ Administer and maintain document control systems to ensure accuracy, integrity, and compliance with cGMP requirements
+ Manage master indices and tracking for key quality documents, including:
+ Standard Operating Procedures (SOPs)
+ Deviation reports
+ Change control records
+ Technical reports and protocols
+ Batch records
+ Validation and non-conformance reports
+ Coordinate documentation workflows to ensure timely drafting, review, ap...
Overview:
We are seeking a detail-oriented Document Control Specialist responsible for maintaining quality documentation and managing document control systems. This role ensures compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory standards, including USFDA 21 CFR Parts 210 and 211, as well as ICH Q7 guidelines for Active Pharmaceutical Ingredients (API).
Key Responsibilities:
+ Administer and maintain document control systems to ensure accuracy, integrity, and compliance with cGMP requirements
+ Manage master indices and tracking for key quality documents, including:
+ Standard Operating Procedures (SOPs)
+ Deviation reports
+ Change control records
+ Technical reports and protocols
+ Batch records
+ Validation and non-conformance reports
+ Coordinate documentation workflows to ensure timely drafting, review, ap...