
System Validation Expert
2 days ago
About Us:
We are a global leader in the software industry, with a workforce of 240,000 employees and operations in over 60 countries.
As a Compliance Specialist, you will be responsible for ensuring the quality and compliance of our systems and processes. You will work closely with cross-functional teams to develop and implement strategies that meet regulatory requirements.
Key Responsibilities:
- Develop and maintain knowledge of FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Conduct risk assessments and develop mitigation plans to ensure compliance with GxP system regulations.
- Collaborate with cross-functional teams to develop and implement validation strategies.
- Develop clear, concise, and timely reports.
- Ability to handle multiple projects and meet deadlines.
Requirements:
- Bachelor's degree in a related field or equivalent.
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Strong knowledge of fundamental cGMP concepts.
- Hands-on experience with EDMS & Test Management tools.
Preferred Skills and Experience:
- Hands-on experience with Microsoft Office.
- Experience with EDMS & Test Management tools.
As a valued member of our team, you will have opportunities for growth and development in a dynamic and supportive environment.
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