Document Reviewer II - QA - Afternoon
Core
Reviewing laboratory data, lab notebooks, Certificates of Analysis, and stability reports to verify data integrity and traceability in a GMP-compliant environment.
Role type
QA Document Reviewer (Pharmaceutical Analytical)
Builds
Ensures compliance and data integrity for pharmaceutical testing and analysis.
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Review of technical documents (batch testing, stability testing, method development), data integrity verification, SOP adherence, change control initiation, SAP system usage, LIMS software usage, TrackWise OOS/DR review, GMP compliance, ICH guidelines knowledge, FDA requirements knowledge, analytical technology understanding (HPLC, GC, UV spectroscopy, titration), Empower software proficiency, Nugensis software proficiency, written communication, oral communication, organizational skills, deadline management, Microsoft Office proficiency, English language proficiency
Preferred skills
None stated
Technologies
SAP, LIMS, TrackWise, Empower, Nugensis, Microsoft Office
Responsibilities
Review regular technical documents and raw data generated in the laboratory, Review and approve TrackWise OOS/DRs, Release Raw Material and Packaging Components in SAP, Release Product Certificate of Analysis using LIMS, Ensure test methods and SOPs are followed by scientists, Verify data integrity and traceability, Follow up with scientists for corrections, Notify supervisors of irregularities, Write/Update SOPs and initiate change control, Maintain safe working environment, Perform rotating shift work
Seniority
Mid-level, hands-on IC
