Position Details
About this role
This role involves ensuring the validation and compliance of computerized systems in the healthcare manufacturing environment, supporting audits and maintaining documentation.
Key Responsibilities
- Validate computerized systems
- Prepare for audits
- Review validation documents
- Manage risk and deviations
- Ensure compliance with GxP standards
Technical Overview
Focus on CSV processes, regulatory compliance, validation documentation, audits, and risk management within a healthcare or pharmaceutical setting.
Ideal Candidate
The ideal candidate is a QA engineer with experience in computer system validation within the healthcare or pharmaceutical industry, familiar with GxP and GAMP standards, and capable of managing audits and documentation.
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 pharmaceutical regulations, No experience with audits or inspections
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