Operational Quality Specialist
Core
Provide operational quality oversight on site to ensure safe, compliant, and reliable supply of medicines and vaccines.
Role type
Operational Quality Specialist (Manufacturing)
Builds
Medicines and vaccines for patients
Domain
Life sciences manufacturing / Pharmaceutical production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, deviation management, CAPA implementation, data integrity, shopfloor observation, regulatory documentation review, change control, validation support, root cause analysis, audit readiness
Preferred skills
biologics manufacturing experience, DMAIC training, inspection readiness knowledge, cross-functional influence, fast-paced environment adaptability
Technologies
robotics, digital solutions, artificial intelligence, GxP systems
Responsibilities
Maintain presence as first line of contact for quality issues; assess work orders and deviations; perform shopfloor walk-throughs; review batch records and CAPA plans; approve disposition decisions; conduct self-inspections and internal audits; ensure GMP documentation compliance; provide real-time guidance during GMP activities; spot-check production, testing, cleaning, and maintenance activities; collaborate on CAPAs and continuous improvement; maintain facility housekeeping standards.
Seniority
Mid-level, hands-on IC
