Senior/ QA Executive (Shift)
Core
Provide dedicated QA oversight and first-line quality support to manufacturing and quality control operations during shift, managing quality-related activities and escalations to maintain cGMP compliance.
Role type
Senior QA Executive (Shift)
Builds
Pharmaceutical manufacturing batches and sterile intermediates
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP standards knowledge, Quality Management Systems (QMS) operation, risk management, batch usage decision making, SOP maintenance, internal audit execution, deviation impact assessment, facility housekeeping compliance, training/coaching
Preferred skills
Subject matter expertise in quality process improvements, change control management, CAPA implementation
Technologies
QMS software, batch record systems
Responsibilities
Ensure GMP processes and personnel adhere to governing procedures; authorize QA processes such as quality tagouts and equipment releases; review and approve batch records and checklists; perform spot-checks of activities for compliance; conduct internal audits and risk assessments; coach employees on quality culture and procedure adherence.
Seniority
Senior, hands-on IC