Compliance Specialist – Validation Support
Position Overview:
The Compliance Specialist – Validation Support assists with audit readiness, validation documentation, and compliance improvement initiatives. This role ensures that validation processes and quality systems adhere to regulatory standards, supporting internal and external audits to maintain compliance.
Key Responsibilities:
Collaborate with validation and quality management teams during audits, preparing and organizing validation documentation.
Lead deviation, CAPA, and change control processes for validation, supporting root cause analysis and resolution.
Schedule and facilitate post-validation lessons learned sessions to improve future project outcomes.
Track metrics related to validation activities, including requalification and periodic reviews, to support continuous improvement.
Required Qualifications:
Bachelor's degree in Life Sciences, Quality Assurance, or a related field.5+ years of experience in compliance and validation within regulated industries. Strong knowledge of GMP, FDA, and other regulatory standards.
