GBS H&N Pharma Quality Assurance Associate
Core
Review and approve Change Control Requests, manage training and document control systems, maintain test methods/specification databases, and coordinate Quality Agreements and audits for pharmaceutical clients.
Role type
Associate Quality Assurance Specialist (Pharma)
Builds
Quality assurance processes, training programs, document management systems, and audit responses for pharmaceutical clients.
Domain
Pharmaceutical Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change control management, training program administration, document control, Quality Agreement coordination, audit support, vendor evaluation, regulatory compliance knowledge (GMP), database maintenance
Preferred skills
Knowledge of USP compendiums, protocol writing, report writing
Technologies
DMS, Microsoft Office (Outlook, Word, Excel)
Responsibilities
Review and approve Change Control Requests (CCRs) and coordinate timely closure; Act as site representative for Training and Document Control systems; Maintain client test methods and specification databases; Coordinate internal, client, and regulatory audits; Prepare responses to audit findings; Release Certificates of Analysis as backup; Perform vendor evaluations; Support operational improvement activities.
Seniority
Associate, operational IC