Senior QMS Specialist: CAPA, Audits & Documentation

Safeguard Global Recruiting; Bogotá; Presencial; COP 120 000 000 - 160 000 000; Tempo integral

Resumo da oferta

Safeguard Global Recruiting is seeking a Senior QMS Specialist to own end-to-end Quality Management System processes for assigned domains, ensuring documentation, CAPA, and audit activities meet ISO and regulatory expectations. You will report to the Manager, QMS, and mentor Junior QMS Specialists while collaborating with Technology process owners to embed quality-by-design in new and revised procedures.

The role requires strong analytical judgment, clear communication, and the ability to

Qualificações

• Bachelor's degree or equivalent applied experience.
• 3–5 years of experience in quality management systems, QA, or regulatory compliance.
• Experience managing CAPA, document control, or change control processes end to end.
• Experience with eQMS or document management platforms.
• Strong analytical, organizational, and communication skills.

Responsabilidades

• Own CAPA lifecycle management for assigned processes and domains: investigation support, root-cause documentation review, effectiveness-check tracking, and closure.
• Coordinate internal audit schedules and readiness activities; serve as point of contact for audit evidence collection and finding remediation tracking.
• Review and approve controlled documentation (SOPs, work instructions) for accuracy, compliance, and consistency with ISO and regulatory requirements.
• Manage change control records for assigned processes, ensuring risk assessment, approvals, and verification.
• Analyze quality metrics and trends and recommend process improvements.
• Support external audits and client or regulatory quality assessments, representing document control and QMS administration.

Conhecimentos

Results & Accountability

Collaboration & Communication

Continuous Improvement

Customer Focus

Business Insight & Strategic Thinking

Trust & Integrity

Formação académica

Bachelor's degree or equivalent

Ferramentas

Veeva QMS

MasterControl

TrackWise

Qualio

ETQ Reliance

Descrição da oferta de emprego

Safeguard Global Recruiting is seeking a Senior QMS Specialist to own end-to-end Quality Management System processes for assigned domains, ensuring documentation, CAPA, and audit activities meet ISO and regulatory expectations. You will report to the Manager, QMS, and mentor Junior QMS Specialists while collaborating with Technology process owners to embed quality-by-design in new and revised procedures.

The role requires strong analytical judgment, clear communication, and the ability to