IT GMP Compliance Documentation

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

We are looking for a detail-oriented specialist to join our client's team in the biotech sector. In this role, you will contribute to supporting ongoing GMP compliance operations, maintaining and executing periodic system reviews, coordinating ServiceNow IT tickets, and managing Change Controls, CAPAs, and Deviations.

Responsibilities

• 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.

Requirements

• 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.

Preferred Qualifications

• Working knowledge of Computer Systems Validation (CSV/CSA).
• Working knowledge of quality systems: Deviations, CAPAs, Change Controls.
• Familiarity with 21 CFR Part 11, EU Annex 11, and ALCOA principles.
• Laboratory systems exposure (e.g., analytical instruments, LIMS, CDS, ELN, instrument control software).

Salary & Benefits

Competitive salary based on experience and qualifications.

• Comprehensive benefits package including health coverage and remote work flexibility.

Who We Are

SGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries.

We’re a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters.

Are you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact?