Computerized System Validation & Data Integrity Specialist
Jubilant Pharma, LLC
Stand out for this role — generate a tailored resume and cover letter in about a minute.
Benefits offered by this job
Job summary
Jubilant HollisterStier Spokane is seeking a Validation Senior Specialist - Computer Systems to lead validation activities for computerized systems and maintain data integrity at the Spokane site. The role covers periodic reviews, audit trails, and qualification documentation in a regulated pharmaceutical environment.
You will draft and review validation plans, URS, risk assessments, and traceability matrices, ensuring compliance with 21 CFR and EMA Annex 11.
Qualifications
- useful background in computer system validation and data integrity within regulated pharm manufacturing.
- experience with building and maintaining CSV documents and validation protocols.
- familiarity with 21 CFR Part 11 and EMA Annex 11 requirements.
Responsibilities
- Perform Periodic Reviews and Audit Trail Reviews of computerized systems.
- Write and review documents to support the qualification of a computerized system.
- Prepare and manage Validation Plans, User Requirements Specifications, Risk Assessments, and Traceability Matrices.
- Develop and review Qualification Protocols, Test Plans and Acceptance Reports.
- Create and maintain Change Control documentation for production computerized systems.
Skills
Education
Tools
Job description
Jubilant HollisterStier Spokane is seeking a Validation Senior Specialist - Computer Systems to lead validation activities for computerized systems and maintain data integrity at the Spokane site. The role covers periodic reviews, audit trails, and qualification documentation in a regulated pharmaceutical environment.
You will draft and review validation plans, URS, risk assessments, and traceability matrices, ensuring compliance with 21 CFR and EMA Annex 11.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
