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Job Description
IT Systems Compliance Engineer required for a pharmaceutical API manufacturing operation. Must have 3-5 years experience implementing and supporting IT applications in a GMP environment.
Main Responsibilities:
- Modify and review existing CSV and compliance documentation for continuous improvement
- Perform privacy, data integrity, and system audit trail assessments for IT systems
- Introduce new IT systems and perform security reviews and periodic reviews
- Work with System Administrators, Subject Matter Experts, and Quality Assurance Representatives to ensure ongoing compliance
- Communicate with stakeholders to understand and clarify software requirements
- Support SharePoint and IT applications, execute test scripts, and analyze test results
- Lead procedural improvements to increase efficiency and consistency of the validation process
- Maintain a tracking system for compliance actions and provide bi-weekly updates
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Support and participate in site audits
Desirable Background/Experience:
- Experience in product life cycles from requirements through design, testing, and delivery of the system into production
- Good knowledge of cGMP required to understand the quality systems on site
- Background in software development, systems analysis/configuration, and Computer System Validation documentation
- Excellent oral and written communication skills with the ability to communicate and build relationships cross-functionally
- Experience implementing changes for IT applications in a GMP environment
- Attention to detail and accuracy
- Ability to meet deadlines
- Experience working in a pharmaceutical API manufacturing operation
Required Skills:
- Validation
- CSV
- GMP
- GAMP5
- Data Integrity
- Pharmaceutical API manufacturing