- The candidate should bring strong experience in deviation management within a GMP/GxP environment, o
wnership of major and minor deviations and the ability to manage the full investigation lifecycle from initiation through closure.
Solid hands-on experience using Veeva QMS to generate, designate, document, and close deviation records.
The candidate must be capable of leading investigations independently, applying structured problem-solving methodologies, and supporting CAPA development and effectiveness verification while maintaining inspection-ready documentation standards.
Since the resource will be managing records related to Computerized systems, the candidate should possess basic to intermediate knowledge of computerized manufacturing systems, including platforms such as MES, SAP, PCS, or PI Historian, to effectively assess and manage deviations related to technology and data integrity.
Requirements
’s degree and 6 years of directly related experience
OR High school diploma / GED and 8 years of directly related experience
8hrs shift | 1st Administration / extended non-standard as needed for deviation closure
Skills Required
- Strong experience in deviation management within a GMP/GxP environment, owning major and minor deviations and managing full investigation lifecycle
- Hands-on experience using Veeva QMS to generate, designate, document, and close deviation records
- Ability to lead investigations independently and apply structured problem-solving methodologies
- Experience supporting CAPA development and effectiveness verification while maintaining inspection-ready documentation
- Basic to intermediate knowledge of computerized manufacturing systems (MES, SAP, PCS, PI Historian) to assess deviations related to technology and data integrity
- Education: Master's degree OR Bachelor's degree + 2 years directly related experience OR Associate's degree + 6 years directly related experience OR High school diploma/GED + 8 years directly related experience
- Willingness to work 8hr shift | 1st Administration with extended non-standard hours as needed for deviation closure
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
