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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer Systems Validation within the GxP environment, including strong knowledge of GLP, GMP regulations, and 21 CFR Part 11. Capable of developing validation deliverables and effectively communicating with project teams and stakeholders.
Highest-signal resume keywords
Computer Systems ValidationGxP RequirementsGLP and GMP RegulationsValidation Plans and Test ProtocolsLaboratory Systems Validation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation PlansTest ProtocolsTraceability MatricesProtocol ExecutionRisk AssessmentsPolicies and Procedures DevelopmentLaboratory Systems ValidationGxP Systems Validation21 CFR Part 11 ComplianceAnalytical Instruments Validation
Soft Skills
CommunicationCollaborationCuriosityStakeholder Engagement
Tools & Technologies
ELNLIMSQMS
Industry Keywords
GxPQuality AssuranceComplianceValidation DeliverablesComputerized Systems
About the role
Key responsibilities & impact- Define validation strategy for computerized systems and/or analytical instruments utilized in GxP space
- Create validation deliverables, including validation plans, test protocols, traceability matrices, and protocol execution
- Participate in user review meetings and discussions with Quality Assurance and Compliance groups
- Participate in or conduct risk assessments
- Develop and maintain policies and procedures
- Communicate validation activities and deliverables to project teams, customer stakeholders, and Zifo’s global team
- Act as liaison between Zifo remote teams and customers in the US and Canada
- Participate in internal Computer Systems Validation initiatives
Requirements
What you’ll need- Bachelor or Master’s degree in Lifesciences or Computer Sciences
- 2+ years’ experience with Computer Systems Validation required
- Strong knowledge of GxP requirements, GLP and GMP regulations, and 21 CFR Part 11 requirements
- Experience with laboratory or GxP systems validation, such as ELN, LIMS, and QMS
- Curiosity and ability to learn new concepts, tools, and emerging technologies
- Must be a Mexican citizen or resident; Zifo Mexico cannot sponsor visas or work permits for non-Mexican citizens/residents
Benefits
Comp & perks- Competitive compensation package
- Accrued vacation
- Healthy Christmas bonus
- Equal opportunity employer
- Diversity-valuing workplace
