QA Inspector – Production & Facility Inspection

About the role

The QA Inspector supports the QA Inspection Manager in ensuring that all production operations and facilities meet Abbott’s stringent quality, safety, and regulatory standards. This role involves on‑site inspection, sampling, documentation, and continuous improvement of quality processes within a GMP‑controlled environment.

Key responsibilities

• Perform GEMBA inspections of production areas, warehouses, utilities, and facilities to verify inspection readiness and data integrity.
• Conduct line clearance and in‑process checks for manufacturing and finishing operations, ensuring compliance with cGMP, GSP, and EHS requirements.
• Sample bulk, intermediate, and finished products according to approved sampling plans.
• Maintain and revise SOPs, ensuring alignment with AQ, EQDs, the Drug Act, and cGMP guidelines.
• Document all activities accurately and timely, supporting data integrity and regulatory compliance.
• Verify calibration and verification of equipment used for in‑process checks.
• Participate in validation and qualification activities for processes, equipment, and facilities.
• Follow up on audit findings, corrective actions, and CAPA implementation.
• Handle exception reports, internal investigations, and customer complaints related to the area of responsibility.
• Ensure workplace safety, report incidents, and support regulatory sample submissions.
• Assist in data collection for PQR and undertake special projects as assigned.

Required profile

• Strong knowledge of current Good Manufacturing Practices (cGMP), Good Storage Practices (GSP) and environmental health & safety (EHS) standards.
• Experience with line clearance, GEMBA inspections, and in‑process sampling.
• Ability to produce and revise SOPs in compliance with regulatory requirements.
• Proven capability to manage documentation, data integrity, and audit follow‑up activities.
• Excellent attention to detail and commitment to maintaining a safe, compliant work environment.

Required skills

• cGMP compliance
• GSP and EHS knowledge
• SOP development and revision
• GEMBA inspection techniques
• Line clearance procedures
• Product sampling methods
• Equipment calibration and verification
• Process validation and qualification
• CAPA management
• Data integrity practices