
Compliance Expert Wanted
1 week ago
We are seeking a highly skilled IT Compliance Specialist to join our team.
A compliance specialist with 4-7 years of experience in regulatory compliance and validation roles, possessing strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 is required. Key responsibilities include system validation aligned with regulatory standards, review of validation artifacts, and identification of traceability or documentation gaps.
Key Responsibilities:
- Hands-on experience in compliance and validation roles
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5
- System validation aligned with regulatory standards
- Review of validation artifacts and identification of traceability or documentation gaps
Requirements:
- Well-versed with System Life Cycle
- Hands-on experience with Validation approach, Agile methodology, AIML concepts
Tools and Technologies:
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems
Quality & Domain Expertise:
- Knowledge of Quality Management Systems (QMS)
- Experience in Healthcare, CRO, or Life Sciences environments
This role offers the opportunity to work in a dynamic environment with a focus on delivering high-quality solutions that meet regulatory requirements.
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