Position Details
About this role
This role involves ensuring the quality and compliance of computerized systems through validation, regulatory adherence, and audit readiness in a pharmaceutical environment.
Key Responsibilities
- Ensure CSV compliance
- Review validation documents
- Prepare for audits
- Maintain regulatory standards
- Collaborate with engineering and QA teams
Technical Overview
The technical scope includes CSV documentation, regulatory standards such as GxP and ICH, and audit management, supporting compliance in healthcare manufacturing systems.
Ideal Candidate
The ideal candidate is a detail-oriented QA CSV engineer with experience in computer system validation and regulatory compliance within the pharmaceutical or biotech industry, capable of managing audits and validation processes remotely.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of CSV experience, No knowledge of regulatory requirements, Inability to work remotely
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