Associate Manager-Quality Review (BQ)
Core
Ensuring quality and compliance in microbiology method verification, validation, and review within a pharmaceutical laboratory setting.
Role type
Associate Manager, Quality Review (Microbiology)
Builds
Validated microbiological testing methods and compliant quality documentation for new product introductions and lifecycle management.
Domain
Pharmaceutical manufacturing / Microbiology / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology method validation and verification, Change control management, Quality risk management (ICH Q9), Laboratory equipment qualification, Regulatory compliance (USP, EP, JP, ICH), Investigation and root cause analysis, Technical writing, Data integrity, Sterility testing, Environmental monitoring, Process and cleaning validation knowledge.
Preferred skills
Experience with Bacterial Endotoxin Test, Kinetic Turbidimetric methods, Media preparation, Regulatory agency inspections, Manufacturing operations basics, Engineering functions.
Technologies
Gel Clot, Kinetic Turbidimetric, Kinetic Chromogenic methods, Membrane Filtration, Direct Inoculation, Isolators, Incubators, MCS reader, Identification systems, HVAC systems, Water systems.
Responsibilities
Execute microbiology method verification and validation, Perform change control assessments, Conduct quality risk assessments, Qualify laboratory equipment, Review analytical method validation data, Lead investigations and root cause analysis, Prepare technical documentation for regulatory submissions.
Seniority
Mid-Senior, hands-on IC with management responsibilities
