Import Vx Quality and Technical Manager

Job description

Nombre del sítio: China - Beijing - ChaoYang District - Ocean International Centre - Tower A, China - Shanghai - Pudong - New Bund International Square
Fecha de publicación: Jan 15 2024

Job Purpose 岗位目的:
This role is designed to drive effective and efficient coordination and support to NIFDC as required during import Vx product release testing, including to ensure in timely communication and documents transmission between NIFDC and Vx global Belgium team, Importation documents package preparation and BRS submission to NIFDC.  The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to ensure that the mandated GSK Quality Management Systems requirements and local GMP relevant regulations are met for all the samples or documents submitted for China import analysis and release. This role is reported to LOCQ China and work closely with supply site Quality in order to mitigate the quality compliance and supply impact to the Commercial Vx business in China market.

Key Responsibilities 主要职责：

1. Quality Strategy

·  Act as a point of contact with NIFDC and GSK Vaccines Manufacturing Sites Quality and Technical Team for import Vx quality tests and release.
·  Batch Brief preparation and translation according to Supply site documents; BRS batch data transcription for China market. Pre-involved BRS definition for newly imported product
·  Importation documents package preparation and BRS submission to NIFDC.
·  U Key application and maintenance for import sampling and testing request.
·  NIFDC release test and BRS review progress coordination according to supply plan. Include NIFDC sampling time coordination with LSP.
·  Supporting Importer to handover the reagents to NIFDC
·  Ensure NIFDC quality/technical inquiries handling and communication precisely with GSK Vaccines Manufacturing Site quality and technical experts in time. Coordination on test method transfer as required.
·  Timely escalation to management for potential risk for batch release or product incidents, and provide resolution to minimize the risk by following GSK procedures.
·  Support for imported vaccines incident investigation as needs.
·  Assess and proactively create and implement a continuous improvement plan for the adoption of the updated local regulation requirements and GSK Quality Management System into the product quality release to the market, includes identifying, understanding and sharing appropriate information.
·  Heighten and promote quality and QMS awareness in the commercial stakeholders and LSP.
·  Build strong relationships with NIFDC and the LOC Commercial Business functions and work with them to develop quality objectives that meet both business and quality objectives.
·  Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
·  Share learning and issues appropriately with other LOC stakeholders and GSK Vaccines Manufacturing sites.
·  Gain learning by on job training from GSK Vaccines network to acquire and maintain knowledge of the manufacture and QC testing of vaccines imported to China
·  Support Vaccines Manufacturing Sites for the preparation, management and response of NMPA inspections.
·  Work closely with Vaccines site conformance for products imported to China and local RA. Support for imported product change control GMP quality evaluations and regulatory dossier variations evaluation as requested from LRA; Provide technical support to RA in communication with Health Authorities; Provide input to RA for the definition and execution of submission strategy; Provide support in the implementation of post-approval commitment as appropriate
·  Lead QA release relevant actions during product registration or project phase and ensure Vaccines manufacturing sites supplying China understands the requirements of Chinese Ph. and regulation.
·  As LOC TTS coordinator to support Vx site on TTS review and approval.
·  After training and qualification, perform LOC quality release for Vx products.

2. Accountability:

QMS Implementation & Sustainability

·  Promote QMS management principles and seek continuous improvement of the batch release to  the market processes
·  Review, conduct impact assessments and implement any updates to QMS policies for product quality release to the market
·  Identify, Implement and Manage relevant QA Objectives & KPIs

Collaborative working

·  Establishes and maintains the trust and professional relationship with NIFDC and relevant external and internal stakeholders.
·  Be able to capture and sharing good practices, quality/technical inquires and drive them to be resolved
·  Defining the required standards and expectations by NIFDC for quality testing and release, periodically reviewing these for continual improvement.
·  Ensure all the documents provided to NIFDC comply to GSK documentation management requirements.
·  Product release and supply - performs day to day work to support systems that have an impact on the quality of imported products in line with the QMS and local Regulatory requirements in the market
·  Ensure timely NIFDC Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.

Training/Education

·  Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans as they potentially link to day to day and quality improvement activities.

Knowledge/ Education / Experience Required知识/教育/经验要求：

A. Educational Background 教育背景：

·  Minimum Level of Education最低教育水平： Minimum Bachelor Degree/desired University Degree in the field of and experience in pharmaceutical industry
·  Area of Specialisation专业领域： Biological, Bio-Chemical, Microbiology, Pharmacy, Chemical engineering or other appropriate education

B. Job-Related Experience 岗位相关工作经验 ：

·  Good understanding of and certain experience in quality control testing, Vx manufacture process, and in the areas of batch release and deviation/Change Control handling

C. Other Job-Related Skills/Background其他岗位相关技能/背景 ：

·  Knowledge of regulatory requirements pertaining to ChP general chapters for Vx product, local sterile GMP and certain QMS knowledge
·  Good knowledge on effective quality documentation management

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

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