Operational Quality Specialist

Maintain compliance with operational guidelines and requirements. Problem Solving Identify and analyze issues within the area of responsibility. Report findings and support resolution of issues, escalating complex matters as required. Coordination Support coordination with internal stakeholders to ensure timely delivery of tasks.

Prepare and provide input for team deliverables as required . Protocols and Compliance Execute and sustain IPC and validation protocols across manufacturing processes, ensuring full alignment with corporate quality standards, approved procedures, and applicable regulatory requirements.

Monitor and verify adherence to IPC and validation activities through structured compliance checks, routine inspections, and real-time observation of shop-floor practices. Identify deviations, non-conformances, and procedural gaps, ensuring timely escalation and follow-up on corrective actions in coordination with QA and production teams.

Support corporate quality reviews and standardization efforts by assessing site-level practices, highlighting inconsistencies, and recommending alignment actions. Maintain accurate, traceable, and audit-ready documentation of all IPC and validation activities, ensuring completeness, integrity, and compliance with internal and external audit requirements.

Ensure that all protocols remain current by supporting periodic reviews, updates, and alignment with evolving corporate standards and regulatory expectations. Data Analysis and Process Improvement Analyze IPC and validation data to identify recurring trends, process variability, and root causes of quality deviations, enabling proactive decision-making.

Translate data insights into actionable recommendations to enhance process capability, reduce defects, and improve overall product quality. Support continuous improvement initiatives by contributing to the implementation of best practices, process optimization, and standardization across manufacturing lines.

Collaborate with corporate quality teams to align site-level improvements with broader quality frameworks and performance objectives. Monitor effectiveness of implemented improvements, ensuring sustained impact on process stability and quality performance.

Issue Resolution and CAPA Management Coordinate with production, QA, and relevant stakeholders to investigate IPC and validation-related issues, ensuring structured problem-solving and timely resolution. Support root cause analysis using established methodologies, ensuring identification of underlying causes rather than symptomatic fixes.

Facilitate implementation of corrective and preventive actions (CAPA), ensuring alignment with quality standards and operational feasibility. Track and monitor effectiveness of CAPA actions, escalating recurring or unresolved issues to ensure sustainable resolution.

Contribute to minimizing operational disruptions and quality risks through proactive identification and mitigation of potential issues. Audit, Compliance and Corporate Quality Interface Support internal and external audits by preparing and providing accurate documentation, evidence, and insights related to IPC and validation activities.

Ensure continuous audit readiness by maintaining well-organized records and adherence to documented procedures. Assist in addressing audit findings by supporting root cause analysis, action planning, and timely closure of observations.

Training, Awareness and Cross-Functional Coordination Conduct and support training sessions on IPC and validation protocols, ensuring operational teams understand procedures, expectations, and compliance requirements. Develop and update training materials in alignment with changes in protocols, standards, and regulatory requirements.

Reinforce quality awareness and accountability across production teams, promoting adherence to quality at source principles. Collaborate closely with production, QA, maintenance, and other functions to ensure seamless integration of quality practices into daily operations.

Support a culture of continuous improvement, operational discipline, and shared ownership of product quality across the site Benefits: Premium Medical Insurance Schooling Allowance Health and Wellness Allowance