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QA Operations Executive

No deviation · Singapore · On-site

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About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally. Position Overview The QA Operations Executive is responsible for providing Quality Assurance oversight to ensure compliance with current Good Manufacturing Practices (cGMP) across Manufacturing and Quality Control operations. The role supports quality-related activities including batch disposition, deviation management, change control, CAPA oversight, documentation review, release authorizations, and audit readiness. Working closely with cross-functional teams, the incumbent ensures product quality, regulatory compliance, and continuous improvement of Quality Management System (QMS) processes while promoting a strong quality culture. Key Responsibilities Provide QA oversight for Manufacturing and QC operations to ensure compliance with cGMP, regulatory requirements, and internal quality standards. Perform routine shopfloor quality oversight including housekeeping inspections, line clearance verification, process confirmations, facility walkdowns, and SOP compliance checks. Manage deviations, laboratory investigations, CAPAs, change controls, and risk assessments to ensure timely resolution and effective corrective actions. Authorize quality-related activities including Quality Tag Outs, conditional equipment releases, campaign changeovers, room releases, batch usage decisions, and release suitability. Review and approve GMP documentation including SOPs, analytical protocols and reports, Master Batch Records (paper and electronic), QC monographs, checklists, deviations, investigations, CAPAs, change controls, and validation documentation. Ensure batch documentation is complete, accurate, and compliant, initiating corrective actions where necessary. Support complaint investigations, internal audits, self-inspections, regulatory inspections, and quality risk assessments. Identify compliance gaps, recommend process improvements, and escalate critical quality issues when required. Own and maintain quality procedures, SOPs, and checklists while delivering training to relevant personnel. Act as a Subject Matter Expert (SME) for quality processes and support continuous improvement initiatives. Support Quality Product Reviews (QPR), quality metrics, KPI reporting, and other Quality Management System activities. Comply with Environmental Health and Safety (EHS) policies and contribute to workplace…