Computer Software Validation Engineer - Pharmaceutical
Role Purpose:
Review Pharmaceutical Machines / Equipment against MHRA, FDA and GAMP compliance regulations and code of practice.
Salary: Circa £55K (Perm 40 hours per week)
Location: WFH and Hertfordshire ( Hybrid )
Role Responsibilities:
1. Key Deliverable
* Validation of software and automation hardware for intended use and user needs. This includes testing R&D pilot plant machines under actual or simulated use conditions.
* Validation of computer system integrity to ensure accurate, reliable, consistent, secure deliverables of computer records and signatures against intended performance.
* Through understanding CSV-V model and its application in machine testing within the Pharma industry
1. Client Management
* Attend regular site reviews via Teams or in person at the clients or manufacturers site
* Validate process and documentation supplied against requirements and give expert feedback.
* Ensure Directors are kept up to date with progress.
* Present monthly client update at company business meetings.
* Project management of technical deliverables against project plan
1. Relationship management
* Develop collaborative relationships that are effective for both the client and for employer.
* Understand client’s values and motivations, ways of working and ordering processes; tailoring your approach to suit their requirements.
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