Related skills
gcp soc gxp ich gmp📋 Description
- Hosts customer audits and supports regulatory audits
- Documents audit findings and authors audit responses
- Conducts internal audits in support of the annual audit plan
- Manages informational requests for internal and external stakeholders
- Performs compliance outreach presentations
- QMS system administration
🎯 Requirements
- BS/BA in Science, Engineering, Information Management, or related field or equivalent
- 3+ years in regulated quality/compliance
- Understanding of life sciences regulations (GxP and/or ICH & ISO)
- Experience hosting audits or regulatory inspections or as SME
- Excellent customer service and collaboration
- Proficient with Microsoft Excel and PowerPoint
🎁 Benefits
- Quality principles for regulated software environments (ISO/IEC/IEEE/ITIL/ICH)
- 2+ years in an audit role in life sciences
- Knowledge of Veeva products
- Understanding of computer system validation
- Knowledge of information security and risk management
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