• Review and approval of executed batch records

• Ensure all records and documentation related to the executed batch record(s) for completeness, accuracy, and compliance of cGMPs and SOPs.

• Provide Quality support for resolution of deviations related to manufacturing activities and department. Maintain oversight of deviations within department.

• Implement CAPAs as required

• Author and/or provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned

?Required Knowledge, Skills, and Abilities

• Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
• Strong communication and organizational skills
• Knowledge in completing investigations and problem resolution
• Knowledge in SAP
• Must have strong ability to critically review investigations, results and provide technical conclusions consistent with Quality risk management principles

Education, Experience, Licenses & Certifications

• Bachelor’s degree with 5 years of relevant GxP industry experience.
• Minimum of 3 years experience in batch review and release
• Excellent understanding of Quality Assurance systems
• Strong communication and organizational skills
• Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
• Knowledge of global regulatory expectations, including FDA and EMA.