The Job Responsibilities of the position holder include :

·      Ensure timely and compliant management of all QC documentation—including Change Controls, SOPs, Raw Data Sheets, GTPs, STPs, and Specifications—in alignment with Abbott AQD/EQD and applicable regulatory guidelines.

·      Lead the preparation, review, and approval of SAP specifications to ensure accurate material and test parameter alignment with regulatory and internal standards.

·      Drive timely evaluation, feasibility analysis, and risk assessment of pharmacopeial updates, ensuring seamless integration into QC systems and documentation.

·      Conduct impact assessments of new and revised regulatory guidelines, ensuring proactive updates to QC practices and documentation.

·      Evaluate and implement QRI actions within defined timelines, ensuring risk analysis and implementation of actions identified.

·      Oversee analytical method validation and verification activities in compliance with ICH, USP, and internal standards, ensuring robustness and regulatory readiness.

·      Manage QC-related activities for new product introductions and technology transfers, ensuring analytical readiness, method transfer, and documentation compliance.

·      Lead preparation and timely closure of audit responses for internal and external audits, ensuring adherence to commitments and continuous audit readiness.

·      Champion continuous improvement initiatives such as Lean Lab, Opti-Q, and method optimization to enhance efficiency, reduce waste, and improve data integrity.

·      Review and approve analytical reports to ensure accuracy, completeness, and compliance with regulatory and internal quality standards.

Ensure training compliance by coordinating laboratory training activities through ISOTrain, maintaining up-to-date training matrices and records.