Associate Manager - QA Review (CQ)
Core
Ensuring quality control in sterile dosage manufacturing through analytical method validation, transfer, and verification.
Role type
Associate Manager, QA Review (Quality Control)
Builds
Sterile dosage forms and analytical testing protocols
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation and transfer, Risk assessment (ICH Q9), Regulatory compliance (USP, EP, ICH Q2), HPLC/GC/IC/ICP-MS operation, Change management, Technical writing, Elemental impurities assessment, Equipment qualification, Investigation and problem-solving
Preferred skills
Knowledge of process and cleaning validation, Water system and HVAC qualification, Manufacturing operations basics, Regulatory agency inspection handling
Technologies
HPLC, GC, IC, ICP-MS, Empower, Potentiometry, UV-Vis, FTIR, Karl Fischer, AAS, XRF, NIR, pH meters
Responsibilities
Review analytical method verification and transfer activities, Perform identification, assay, purity, and related analytical tests, Apply risk-based principles for quality risks, Interpret analytical data against procedure requirements, Assess test method requirements for New Product Introduction, Handle regulatory agency inspections
Seniority
Manager, hands-on IC
