Remote GMP IT Compliance & Validation Specialist

SGF Global; Colombia; Híbrido; COP 66.960.000 - 111.600.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Remote work flexibility

Descripción de la vacante

SGF Global seeks a detail-oriented GMP Compliance Specialist to support ongoing compliance operations in the biotech space. You will lead periodic reviews of validated lab and manufacturing systems and coordinate ServiceNow IT tickets to ensure SLAs and regulatory readiness.

Responsibilities include coordinating Change Controls, CAPAs, and Deviations, and updating validation documentation in response to findings and approved changes, with focus on audit-ready deliverables and strict adherence to

Formación

• 2–5 years in a GMP-regulated environment (pharma, biotech, or life sciences).
• Experience with GMP documentation such as validation deliverables, technical writing, and SOPs.
• Strong MS Word, Excel, and PowerPoint skills; able to produce audit-ready and audience-ready documentation.
• Familiarity with FDA and EMA regulatory expectations.

Responsabilidades

• Lead GMP periodic reviews of validated systems (lab and manufacturing) within defined cycles.
• Coordinate and track IT service tickets in ServiceNow to meet SLAs and compliance needs.
• Coordinate and support Change Controls, CAPAs, and Deviation activities.
• Execute validation documentation updates required by periodic review findings and approved change controls.

Conocimientos

GMP experience

ServiceNow

CSV/CSA

CAPA management

Change controls

Deviations handling

Technical writing

Audit readiness

LIMS

Herramientas

MS Word

MS Excel

MS PowerPoint

LIMS

Descripción del empleo

SGF Global seeks a detail-oriented GMP Compliance Specialist to support ongoing compliance operations in the biotech space. You will lead periodic reviews of validated lab and manufacturing systems and coordinate ServiceNow IT tickets to ensure SLAs and regulatory readiness.

Responsibilities include coordinating Change Controls, CAPAs, and Deviations, and updating validation documentation in response to findings and approved changes, with focus on audit-ready deliverables and strict adherence to