Facilities Quality and Compliance Specialist (GMP Lab)
Core
Ensures facilities and maintenance activities are planned, executed, and documented in compliance with 21 CFR, GMP requirements, and internal quality systems.
Role type
Facilities Quality and Compliance Specialist
Builds
Compliant facility operations and documentation for GMP labs
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Deliverable
client delivery
Required skills
Change control management, risk assessment, deviation investigation, CAPA development, audit support, lifecycle compliance documentation, CMMS/CAFM system proficiency, building systems knowledge
Preferred skills
Electrical/plumbing/mechanical construction knowledge, vendor management, drawing validation
Technologies
Microsoft Office Suite, CMMS / CAFM systems
Responsibilities
Partner with Facilities and Maintenance teams to ensure compliant use of CMMS / CAFM systems; Author, manage, and assess Change Controls related to facilities, utilities, and infrastructure; Support deviation investigations, CAPA development, and effectiveness checks; Support internal and external audits and regulatory inspections; Provide compliance guidance for facilities-related commissioning, qualification, and validation activities; Partner with Procurement to support maintenance contracts.
Seniority
Mid-level, hands-on IC
