The role involves leading the complete lifecycle of GMP documents including SOPs, quality standards, and batch records to ensure version control and regulatory compliance
Job Summary
The role involves leading the complete lifecycle of GMP documents including SOPs, quality standards, and batch records to ensure version control and regulatory compliance.
Candidates must maintain a robust document management system that adheres to data integrity principles like ALCOA+ and electronic record regulations such as 21 CFR Part 11.
The specialist will serve as the primary interface for internal and external audits, providing necessary records and managing corrective action closures related to documentation.
Matching Summary
The role involves leading the complete lifecycle of GMP documents including SOPs, quality standards, and batch records to ensure version control and regulatory compliance.
Skills & Requirements
Must-have
GMP file lifecycle management
21 CFR Part 11 compliance
ALCOA+ data integrity principles
EDMS system proficiency
Internal and external audit support
Nice-to-have
Process optimization skills
Strong communication abilities
Team collaboration spirit
English language proficiency
Key Requirements
Bachelor's degree in Pharmacy or Life Sciences
3+ years experience in pharmaceutical GMP environment