Operational Quality Assurance Officer
Core
Ensure adherence to GMP standards through independent oversight of GMP processes, manage quality escalations, and maintain inspection readiness in pharmaceutical manufacturing.
Role type
Operational Quality Assurance Officer (GMP)
Builds
Pharmaceutical products (specialty medicines and vaccines)
Domain
Biopharma / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation management, batch documentation review, validation oversight, risk assessment, SOP approval, sampling procedures, incident investigation, quality culture coaching
Preferred skills
EHS knowledge, GPS implementation, budgetary control, team management
Technologies
Word, Excel
Responsibilities
Conduct spot-checks in production, warehouse, utilities, and laboratory areas; Review and approve quality documents (SOPs, batch records); Act as QA reviewer in deviations and handle customer complaints; Oversee OQ measures during validation batches; Deliver Stop for Quality training and foster quality culture; Monitor facility housekeeping standards and escalate deviations.
Seniority
Entry-level to Mid-level, hands-on IC
