Safetec of America, Inc. has been your trusted source for infection control, first aid, and compliance products for over 30 years. We are a fast-growing OTC pharmaceutical company located in Buffalo, NY. We are a family-owned, local business with a reputation for retaining employees because we treat them like family. The Computer System Validation Engineer (CSV) will be responsible for all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will oversee validation activities, develop and approve validation documentation, and risk assessments, work with project teams to resolve elements that should be validated, and conduct impact assessments of proposed changes to computerized systems. The employee will provide vital oversight of system-related issues, utilize risk-based methodology, and ensure that all GxP computerized systems are validated throughout their lifecycle. Additionally, the initiatives focus on providing consistent policy administration, implementing key improvement initiatives, and solving compliance issues.
Responsibilities
Qualifications
The ideal candidate will have experience;
The ideal candidate will have a strong understanding of;
Education/Experience
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