Quality Assurance Officer
Core
Ensuring compliance to cGMP requirements through real-time quality support, batch record reviews, and operational audits within a pharmaceutical manufacturing environment.
Role type
Quality Assurance Officer (GMP regulated environment)
Builds
Pharmaceutical products requiring strict quality control and regulatory compliance
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, batch record review, deviation investigation, process validation review, internal auditing, risk assessment, SOP updating
Preferred skills
Experience in Quality Assurance within GMP regulated environments
Technologies
Quality Management Systems, Microbial Mapping validation, resin re-use protocols, cleaning validation protocols
Responsibilities
Perform real-time batch record reviews and final QA approval of batch documentation; Conduct routine audits of logbooks for cGMP compliance; Participate in deviation investigations and risk assessments; Update SOPs to meet regulatory standards; Serve as a resource for operational areas on quality issues.
Seniority
Mid-level, hands-on IC