
Dedicated IT Compliance Specialist
3 days ago
We are seeking a dedicated IT Compliance Advisor to join our team. As an IT Compliance Advisor, you will be responsible for ensuring that our IT systems and processes comply with relevant regulations and industry standards.
The ideal candidate will have hands-on experience in compliance and validation roles, strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5, and the ability to review validation artifacts and identify traceability or documentation gaps.
- Key Responsibilities:
- Compliance and Validation: Ensure that all IT systems and processes comply with relevant regulations and industry standards.
- System Life Cycle and Methodologies: Develop and implement system life cycle methodologies to ensure efficient and effective use of resources.
- Testing/Validation Experience: Plan, execute, and report on testing and validation activities to ensure that all systems meet regulatory requirements.
- Tools and Technologies: Utilize various tools and technologies to support compliance and validation efforts, including HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- Quality & Domain Expertise: Provide guidance and support on quality management systems (QMS) and domain expertise in healthcare, CRO, or life sciences environments.
Requirements:
- Bachelor's degree in a related field.
- 4-7 years of experience in compliance and validation roles.
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
- Familiarity with risk-based validation and data management.
Benefits:
- A competitive salary and benefits package.
- Ongoing training and development opportunities.
- A dynamic and supportive work environment.
Others:
If you are a motivated and experienced IT Compliance Advisor looking for a new challenge, please submit your application today
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