QA Specialist A
Core
Ensuring pharmaceutical products meet high quality standards and comply with GMP and internal requirements by investigating deviations, complaints, and quality issues.
Role type
Quality Assurance Specialist (Pharmaceuticals)
Builds
Maintains product quality and patient safety compliance within a regulated environment.
Domain
Pharmaceuticals / Regulated Manufacturing
Deliverable
client delivery
Required skills
GMP compliance, deviation investigation, audit participation, CAPA planning, complaint report writing, process standardization, document review (GxP/QMS), trend analysis
Preferred skills
Project coordination, stakeholder collaboration, independent task ownership, process improvement
Technologies
QMS, GxP documentation systems
Responsibilities
Handle and investigate deviations, complaints, and quality issues; Support and participate in audits and inspections; Review and approve quality documents (GxP / QMS); Maintain Basic Product Specifications (BPS); Write and manage CAPA plans for audit findings and complaints; Prepare complaint reports with trend analysis; Coordinate Product Quality Reviews (PQR)
Seniority
Mid-level, hands-on IC