
Regulatory Compliance Specialist
18 hours ago
The company seeks a qualified professional to assume the position of Compliance Advisor. The successful candidate will be responsible for ensuring adherence to regulatory standards across various systems and processes.
About the Role:
- To ensure compliance with GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations by conducting thorough reviews and validation audits.
- Prepare test plans, validation plans, risk assessments, requirement traceability matrices, and summary reports.
- Participate in internal and regulatory audits to identify areas for improvement and ensure ongoing compliance.
- Maintain strong knowledge of quality management systems (QMS) and industry best practices.
- Collaborate with cross-functional teams to implement changes and improvements.
Requirements:
- Minimum 4-7 years of experience in compliance and validation roles.
- Strong understanding of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- Experience in Healthcare, CRO, or Life Sciences environments.
Education:
Bachelor's degree or equivalent required.
Key ResponsibilitiesThe Compliance Advisor is expected to take on the following key responsibilities:
- Conduct regular audits to verify system compliance with relevant regulations.
- Develop and maintain accurate records of audit results and compliance status.
- Collaborate with other departments to ensure effective implementation of compliance measures.
Professional Qualifications
- Demonstrated expertise in GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
- Proven ability to analyze complex data and make informed recommendations.
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