Job Description

The Document Control Specialist is responsible for printing and reviewing batch records and working with the Quality team to ensure accuracy. This role ensures that all processes are carried out in compliance with Good Manufacturing Practices (GMP) and safety regulations.

Key Responsibilities:

• Print and review paper batch records for compliance with Good Documentation Practices (GDP)
• Reconcile batch records and collaborate with Quality Assurance on necessary comments and changes
• Ensure accuracy and completeness of documentation in accordance with GMP standards
• Enter data into GLIMS (Laboratory Information Management System) as needed
• Maintain organized and detailed records to support manufacturing and quality operations
• Adapt to daily changes and shifting priorities in a fast-paced environment

Qualifications:

• Minimum 1 year of experience in a GMP-regulated environment
• Strong understanding of GDP and document control processes
• Experience with GLIMS or similar data entry systems preferred
• Highly detail-oriented and organized
• Self-motivated with the ability to work independently
• Comfortable with change and agile in day-to-day responsibilitie

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