Senior Executive
Core
Senior executive responsible for Quality Assurance in a pharmaceutical laboratory, managing document control, SOP approvals, change control, deviations, and internal audits for OSD and injectable products.
Role type
Senior Quality Assurance Executive (Pharmaceuticals)
Domain
Pharmaceuticals / Quality Assurance
Deliverable
dashboards & analysis
Required skills
cGMP compliance, SOP development and review, change control management, deviation investigation, internal audit execution, risk assessment, document control, calibration oversight
Preferred skills
cGLP compliance, risk assessment reporting, laboratory management
Technologies
None stated
Responsibilities
Prepare and approve specifications, test procedures, and APIs for OSD and injectables; Review and sign off ARD, FRD, and DQA SOPs; Manage change control assessments and closures; Handle deviations and lab-related notifications; Conduct internal audits; Prepare risk and justification reports; Oversee calibration and document cell maintenance.
