Regulatory Compliance Specialist

Position: Regulatory Compliance Specialist Role
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 years of relevant pharmaceutical experience

• Degree in science or equivalent

• Strong leadership and decision-making skills

• Excellent interpersonal communication capabilities

Apply your compliance expertise at Resilience to contribute to the evolving landscape of biomanufacturing.
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