Join Resilience as a Regulatory Compliance Specialist to impact biomanufacturing positively. In this role, focus on maintaining high compliance standards across manufacturing processes.
The role emphasizes supporting the manufacturing team in upholding a strong cGMP framework in line with client and regulatory expectations. You will be responsible for reviewing Batch Production Records, managing compliance documentation, and addressing audit findings. Your leadership and problem-solving skills will be vital as you enable departments to meet compliance objectives while fostering a culture of accountability.
Key Responsibilities:
• Review Batch Production Records for compliance completeness
• Assist in CAPA actions and investigative processes
• Conduct inspections to ensure GMP adherence
• Facilitate timely closure of audit observations
• Support staff in implementing GMP processes and procedures
Requirements:
• Understanding of GMP and FDA regulations
• 1-3...