Execute on‑site quality assurance activities, including audits, inspections, walkthroughs, and compliance checks, to verify adherence to approved SOPs, manuals, and internal controls.
Validate SOPs, manuals, and work instructions under real operating conditions by assessing actual practices against documented procedures, identifying gaps, and escalating findings with clear, actionable feedback.
Support the development, review, and continuous improvement of SOPs and operational manuals by providing ground‑level observations, audit evidence, and validation inputs in close coordination with process owners.
Conduct incident investigations and Root Cause Analysis (RCA) in partnership with operations teams, ensuring conclusions are factual, evidence‑based, and clearly documented.
Draft, track, and follow up on corrective and preventive actions (CAPA), verifying effective implementation and ensuring actions adequately address identified root causes.
Prepare, maintain, and organize audit records, evidence, and documentation to ensure accuracy, completeness, traceability, and readiness for internal and external audits.
Monitor compliance trends, recurring deficiencies, and systemic issues, escalating risks, deviations, and repeat findings to management in a timely manner.
Participate in table‑top exercises, simulations, and operational readiness activities to assess SOP effectiveness, escalation mechanisms, and control robustness.
Engage and educate ground teams to clarify quality requirements, reinforce correct practices, and strengthen understanding of the intent behind SOPs and control measures.
Promote a positive quality culture by positioning quality assurance as preventive, practical, and supportive of safe, compliant, and effective operational performance.
Key Requirements
Job Requirements
Basic understanding of Quality Management System (QMS) concepts, Standard Operating Procedures (SOPs), and audit principles.
Ability to observe operational activities, collect objective evidence, and accurately document findings during audits, inspections, and walkthroughs.
Foundational analytical and problem‑solving skills to support incident investigations, root cause analysis, and corrective and preventive action (CAPA) follow‑up.
Clear and effective communication skills to explain quality requirements, procedures, and audit findings to frontline and ground teams.
Willingness and ability to work in operational environments, engaging directly with frontline staff to assess practices and reinforce quality standards.
ISO 9001 Internal Auditor certification or equivalent quality‑related certification is preferred.
Demonstrated collaboration and change management capabilities, including the ability to work across cross‑functional teams and manage internal and external stakeholders.
Highly motivated, analytical, and detail‑oriented, with strong problem‑solving skills and the ability to manage competing priorities in a fast‑paced environment.
