GxP System Specialist
6 days ago
We are seeking an experienced GxP Systems Specialist to implement and manage Oracle ERP implementations at our client site and other GxP applications to ensure compliance with regulatory requirements and business needs.
REQUIRED SKILLS
- GxP Impact Assessment
- User Requirement Specification document
- 21 CFR Part 11 assessment document
- Deliver Compliance and GDP Training
- Build Validation Plans
- Build and maintain Requirements Traceability Matrix (RTM)
- Create and maintain IQ, OPQ, and PQ protocols; execute and document them
- Deliver Validation Summary Report
- Computer System Validation: Proficient in validating computer systems for various industries, especially Lifesciences, Healthcare, Biotech, Pharmaceuticals
- GxP Compliance: Ensuring adherence to Good Practices in industries like pharmaceuticals and healthcare.
- GMP (Good Manufacturing Practices): Expertise in maintaining quality standards in manufacturing processes.
- SOP Writing: Craftsmanship in developing clear and effective Standard Operating Procedures.
- 21 CFR Part 11 Compliance: Adept at implementing electronic record-keeping and electronic signatures.
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