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3 days ago
We are seeking a skilled IT Compliance Advisor to join our team. As an IT Compliance Advisor, you will be responsible for ensuring that our systems and processes meet regulatory standards.
The successful candidate will have hands-on experience in compliance and validation roles, with a strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
Required Skills and Qualifications:- Compliance and Validation: Hands-on experience in compliance and validation roles.
- System Life Cycle and Methodologies: Well-versed with System Life Cycle and hands-on experience with Validation approach, Agile methodology, AIML concepts.
- Testing/Validation Experience: Review and preparation of Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports, understanding of the defect lifecycle and validation deliverables.
- 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) and experience in Healthcare, CRO, or Life Sciences environments.
- Experience with SaaS validation, automation, and vendor audits.
- Participation in internal/regulatory audits.
- Strong documentation skills (SOPs, templates, work instructions).
- Familiarity with risk-based validation and data management.
Educational Qualification: Any Graduate.
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