QA Specialist
Core
Ensures compliance with cGMP and safety regulations for sterile pharmaceutical production by managing QA activities, reviewing batch records, and handling deviations.
Role type
QA Specialist (Sterile Manufacturing)
Builds
Production batches compliant with regulatory standards
Domain
Pharmaceutical industry, sterile manufacturing
Required skills
Batch record review, deviation management, CAPA tracking, change control, internal audit documentation, risk management, regulatory compliance monitoring, client complaint investigation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Collaborate with QA Manager to manage QA group activities; Execute batch record reviews; Draft Quality Assurance procedures; Support production in managing deviations and tracking CAPA; Prepare QA documentation; Collect data and draft PQR and APR documents; Document internal audits; Investigate customer complaints and non-conformities; Monitor risk management activities; Support on-site audits by external suppliers; Support QA Manager during regulatory agency inspections
Seniority
Mid-level, 2-3 years experience
