Senior Executive, Quality Operations, ACI HalthCare PLC

✅ To prepare SOPs and other relevant master documents as and when required.
✅ To review all logbooks, data sheets, and other GMP-related documents and ensure compliance.
✅ To ensure readiness and perfect technical status of all QC Instruments, Equipment, Reference/Working Standards and Reagents.
✅ To conduct timely execution of Periodic calibration and preventive maintenance of different analytical instruments and equipment as per procedure specified in the approved SOP.
✅ To maintain GxP in all aspects by following Company’s Quality Module and Quality Manual, relevant SOPs, Guidelines of DGDA, USFDA, WHO, EU, ICH and other relevant international regulatory bodies (Here, x denotes Manufacturing, Laboratory, Documentation, Hygiene etc.).
✅ To develop and validate applicable analytical methodologies.
✅ Preparation of Working Standards from already released materials as per plan within required timelines.
✅ To support regulatory submission by execution of different analytical work, preparation, and review of analytical documents within required timelines.
✅ To ensure availability of all types of resources (e.g., Reagents, equipment, etc.) through gap analysis as per requirement and when applicable.