About the Company
The IT Computer Systems Compliance Engineer will be responsible for on‑going IT application and compliance support within the IT Team. They will need to have experience in implementing and supporting IT applications, technical writing, and document management in a regulated environment.
The IT Computer Systems Compliance Engineer will need to have a strong quality background to maintain quality standards in a GMP environment.
The position will work within a collaborative IT team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
Compliance experience in the areas of Data Privacy, Data Integrity and Information Security for computer systems is desirable.
Experience of working in a pharmaceutical API manufacturing operation is desirable.
Experience
* Minimum 3‑5 years’ experience implementing and supporting IT applications in a GMP environment
* 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
* Strong oral and written communication skills are required, with proven 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
Role will Involve
* Modify and Review existing CSV & Compliance documentation (e.g. Standard Operating Procedures, templates, strategy documents) focusing on continuous improvement and following up on gaps or discrepancies
* Privacy, Data Integrity and System Audit trail assessments for IT systems
* Introduction of new IT systems
* Perform Security Reviews and Periodic Reviews for IT systems
* Work directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives ensuring ongoing compliance with Lilly Quality Standards and Practices
* Communicate with stakeholders to understand and clarify software requirements
* Support of Sharepoint and IT applications
* Execute test scripts, analyze test results and determine the acceptability of results against pre‑determined criteria
* Work with the business to identify and implement procedural controls to mitigate issues found during testing
* Lead procedural improvements that will increase efficiency and consistency of the validation process
* Maintain 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
Skills
* GMP
* CSV
* GAMP5
* DATA INTEGRITY
* IT APPLICATIONS
* PRODUCT LIFE CYCLE
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