Job Summary:
Ensure compliance with regulatory requirements and industry standards through thorough batch record reviews within the pharmaceutical and biotech industries.

Job Requirements:

• Extensive knowledge and expertise in quality assurance within the pharmaceutical and biotech industries
• Strong understanding of Good Manufacturing Practices (GMP)
• Experience in batch record review for compliance with GMP, SOPs, and regulatory requirements
• Familiarity with FDA, EMA, and other relevant regulatory agencies' requirements
• Ability to work collaboratively with cross-functional teams

Job Responsibilities:

• Conduct detailed reviews of batch records for completeness, accuracy, and compliance with GMP, SOPs, and regulatory requirements
• Document, investigate, and resolve discrepancies, deviations, and non-conformances before batch release
• Collaborate with manufacturing, quality control, and other departments to ensure batch records meet all quality and compliance standards
• Provide recommendations for improvements in batch record documentation processes
• Assist in the development and implementation of quality assurance processes and procedures to enhance batch record accuracy and completeness
• Support internal audits and regulatory inspections, providing necessary documentation and responses related to batch record reviews
• Participate in risk assessments and CAPA related to batch record discrepancies
• Ensure all batch record review activities comply with FDA, EMA, and other relevant regulatory agencies' requirements
• Provide training and guidance to manufacturing and quality teams on best practices for batch record documentation and review