Quality Associate
Core
Manage product technical complaints, quality events, and regulatory interactions to ensure compliance and timely resolution.
Role type
Quality Associate (Pharmaceutical QA/QC)
Builds
Quality documentation, CAPAs, and regulatory compliance for biopharma products
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
GxP quality systems, complaint/deviation handling, analytical method validation, quality agreements, GMP training support, audit coordination, regulatory liaison
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage product technical complaints and monitor investigation activities; Handle quality events including deviations, change controls, and CAPA activities; Coordinate analytical method validation and transfer activities; Maintain quality agreements with manufacturing sites and third-party suppliers; Support product release activities in compliance with local regulatory requirements; Maintain quality documentation and training records; Support delivery and tracking of GMP and quality-related training activities; Support quality audits and inspections including health authority inspections; Follow up on inspection observations and CAPAs; Liaise with local health authorities regarding quality-related regulatory requests; Serve as backup for Annual Product Quality Review activities
Seniority
Mid-level (2-5 years experience)