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Overall purpose of job The Commercial Quality (CQ) Specialist supports the Commercial Quality Manger, to ensure the quality of, and meeting the applicable requirements for, the products that Janssen China markets and/or the products under J&J company which take responsibility by China CQ team. He/she is serving as change agent for digital transformation of Janssen China Customer Care Center, has a supporting role to establish the new ways of working for customer care center from online channel and compliance with the local laws/regulations and the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities Janssen China. In this role he/she supports the CQ Mangers with the establishment, implementation and maintenance of the quality system & processes and is dedicated to continuous improvement thereof. Key responsibilities 1. Document, Data and Change Controls Create, timely review and revise/maintain LOC procedures related to PQC management in accordance with local GxP, QMS and J&J requirements. Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention and disposition) to ensure regulatory compliance and business continuity. Ensure appropriate internal and external change control systems are followed. 2. Qualification and Training Support the preparation, revision, training and implementation of global CQ/local LOC procedures in accordance with local GxP, QMS and J&J requirements and support the provision of appropriate GxP/product training for all job functions. 3. Inspection and audit management Support the preparation, execution and follow up for external inspections & internal audits. 4. Events and Deviation Management Ensure that all events and deviations for Janssen China products and critical systems are timely handled, documented, investigated for root cause and assessed for its impact on product quality and safety. Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event/deviation as well as to prevent recurrence in the future. 5. Regulatory Compliance Support for monitoring, reviewing, assessing, tracking and implementing applicable CCC related regulatory requirements (e.g. data privacy) which ensure continued suitability and effectiveness and satisfy the J&J and regulatory requirements. 6. Support for Computer System Validation (CSV) and system management, ensuring that GxP systems meet regulatory requirements and operate within established protocols. Required Qualification and Core Competencies BA/BS, advanced degree or equivalent preferred High level of integrity and compliance concept with good ethical core values Knowledge of pharmaceutical or other regulated industry is preferred, ideally with a mix of Quality and Compliance, Pharmacovigilance, Regulatory Affairs Demonstrate strong organizational, interpersonal and communication skills Highly self-motivated, strong agility and resilience Independent and objective thinker Manages conflicts in and open and constructive manner Fluent in both Chinese and English (reading, writing, verbal) Master of Microsoft Office software (Word, Excel, PPT)