Compliance QA Senior Manager (职位编号：R-122434)社

面议

无锡市

发布时间：2023-09-06

职位描述

Responsibility:
Monitors and ensures compliance with cGMP and regulations within changing regulatory environment.AZ QCM requirements assessment and implementation.Identify the quality and compliance gap and work out improvement plan with area manager, as well monitor the implementationReview and approve the documentation to be used in regulatory submission, and ensure the timely submission and appropriate contentLeading all internal and external inspection management and ensure license to operate.Maintains and implements cGMP, Regulations, AstraZeneca Quality & Compliance policies and procedures as well as industry best practices for Quality Systems. Ensures Quality Assurance systems are in place and implemented across in whole siteWuxi PQS managementQA related e-system managementQuality management with supply site, contracted manufacturer and CustomerEstablishes and continuously improves of quality systems across the organization and ensures aligned with Global PQS strategy.Leads key compliance performance measures and the implementation of site compliance initiatives and procedures across the siteProactive surveillance, advocacy, engagement and interpretation of regulations that allows us to both influence and be ready for changeEffective interaction and maintain relationship with regulatory authorities for business needs.Proactively work with Global Quality network and QA at other sites to share best practices and learning.Collaborate with other functions within sites to drive continuous improvement and maintain regulatory compliance across site.People ManagementSHE Responsibility
Requirements
Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.Good skills of English communicationOverall quality management system and GMP/GDP knowledgeRich prior experience in GMP area of？ Quality and compliance management environmentMultiple of working experience across regulatory affairs, manufacturing, QC or QA management, etcExperience of establishing and sustaining regulatory compliance cultureExperience of internal and external multiple China/oversea Agency audit managem**********************

其他要求

招聘人数：1人
职能类别：

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