李志霞 Email and Phone Number

Job description: Responsible for supervision/oversight/guidance to operations, ensure compliance with cGMP& J&J policy requirements, and dedicate to promote continuous improvement in quality system.- On-site management: perform inspection for the routine GMP implementations, timely provide correction and preventive measures for findings, tracking the completion and effectiveness of CAPAs; - Document review:Review and approve the standard operational process to ensure compliance with GMP and internal procedure requirements, review and approve the master data;Review and approve blank batch records;Review manufacturing and packaging batch records, and review batch records of new launch products, rework batch records, rework orders, and validation batch records;- System management:Coordination and handling of exceptional and non-compliant incidents, ensuring that relevant investigations comply with regulatory requirements and continuously improving the efficiency and effectiveness of investigations, recommending the disposal of materials and decisions of impact products; Carry out the impact assessment of the operations on the change and track the implementation activities;Handle quality complaints from external customers to meet their potential needs;Responsible for plant pollution prevention, cross-contamination and mix-up procedures, annual reviews and gap analysisDraft products quality review report;Relevant quality training for production personnel;

QA part:1. Review and handle exceptional events, including laboratory investigations, supplier complaints, and other deviations, to ensure that the relevant investigations comply with regulatory requirements and continuously improve the efficiency and effectiveness of investigations; Responsible for drafting the annual deviation report, accurately identifying abnormal trends, analyzing data from different angles, identifying opportunities for improvement; 2.       Acts as a deviation system key user, responsible for the management of the plant deviation system Trackwise, and trains the deviation investigator and the deviation owner3.       Responsible for the release of batch records, to ensure that the production process in line with GMP regulatory requirements and Novartis quality standards, within the prescribed time limit to release to ensure market supply;4.       Acts as deviation system/safety information update SME, drafts/updates relevant SOPs and trains relevant personnel, and is responsible for the gap analysis of departmental SOPs and EU,WHO,FDA related regulations;5.       Conduct daily supervision and inspection of GMP to track the completion and continuous improvement of CAPA; 6.       Responsible for audit preparation and support of Quality Department, such as WHO,GCA,MHRA, etc. QC parts1.       Responsible for the management of QC laboratory analytical methods, including method evaluation, change and implementation, pharmacopeia monitoring (ChP,EP, USP) and implementation; 2.       Solve the technical trouble shootings of laboratory analysis;3.       Review Q C related SOPs/FRMs to ensure compliance with GMP regulatory requirements, review and approve analytical records templates, training materials, etc 4.     Coordinate the QC analyst inspection.

Performed chemical tests for API and HFP;Responsible for drafting project dossier in analysis part and submitting to government