QA Data Reviewer
Core
QA Data Reviewer ensuring technical quality and compliance of laboratory data, reports, and documentation in a pharmaceutical GxP environment.
Role type
Senior QA Data Reviewer (Pharmaceutical/Analytical)
Builds
GMP-compliant analytical test results, Certificates of Analysis, reports, and quality documentation for psychedelic therapeutics.
Domain
Pharmaceutical industry, Analytical Chemistry, GxP/QA
Required skills
Pharmaceutical analytical laboratory methods, LC/MS/MS, HPLC, GC/MS, cGMP/GMP/GDP/GxP regulations, SOP development, OOS/OOT investigation, data integrity, regulatory compliance (FDA/Health Canada/ICH), equipment qualification
Preferred skills
Method development, stability studies, change-control documentation, audit coordination, CAPA management
Technologies
Excel, Microsoft Office
Responsibilities
Review QC and R&D data, reports, protocols, and analytical results for technical quality and compliance; Identify analytical testing deviations, OOS, and OOT results; Coordinate laboratory investigations (deviation, OOS, OOT, change-control, CAPA); Develop GMP documentation including SOPs and forms; Guide laboratory staff on GxP best practices; Prepare and approve analytical test results and Certificates of Analysis; Coordinate internal, client, supplier, and regulatory audits; Review equipment and instrument qualification and maintenance records.
