Quality Management Systems Executive

Job description

Nombre del sítio: Singapore - Tuas
Fecha de publicación: Feb 28 2024

Purpose

To lead, support and maintain effective and compliant quality systems relating to:

·  Deviation Management System
·  Corrective Action and Preventive Action (CAPA) System
·  Change Control System
·  Product Quality Review (PQR)
·  Quality Management System (QMS)
·  Quality Alerts and Quality Bulletins

Key Responsibilities

General

For each assigned Quality System(s) :

·  Lead in its design and maintenance to be compliant with regulations, QMS, company policies and site specific requirements
·  Be the subject matter experts (SMEs) for the site
·  Be proficient in the respective SAP and IT modules
·  Provide business support to site employees
·  Review and revise the relevant SOPs
·  Manage the relevant training programs, such as maintaining the training schedule, training materials and trainers
·  Perform gap assessments between local procedures and above-site documents, such as Vaccines SOPs (VSOPs) and QMS
·  Perform periodic reviews as required, such as annual Deviation Management System review
·  As a site representative, create effective interfaces with internal and external stakeholders such as global and fellow process owners to share best practices and drive continuous improvements

Deviation Management System

·  Review and track Deviation investigations, including overdue deviation investigations, investigation extension requests and highlight significant trends or patterns of recurrence
·  Perform review of deviations and CAPA to identify trends (Quality Trend Reviews) to monitor the overall performance of operations and identify potential system-based problems and present to Site Quality Council (SQC)
·  CAPA System
·  Ensure consistent application of CAPA systems
·  Review and monitor CAPA system, and report CAPA metrics to SQC
·  Product Quality Review (PQR)
·  Adherence to Global PQR Schedule
·  Generate PQR in accordance with GSK Vaccines PQR Template
·  Leads the site in the drafting and compilation of the PQR report
·  Quality Alert and Quality Bulletins
·  Work with internal stakeholders to manage and coordinate the site's responses to Quality Alerts and Quality Bulletins in a timely and effective manner
·  Summarizes all received Quality Alerts / Bulletins and reports them to SQC
·  Site Change Control
·  Runs the regular site Change Control Board and implementation committee meetings with relevant stakeholders
·  Ensures the consistent application of criteria to determine change control levels for each proposed change
·  Review and monitor the health of the Change Control system on site; e.g. change control status, duration of change controls and provide relevant metrics to SQC
·  Drafts the Local Summary Report

Skills, knowledge & experience

Professional

·  At least University basic degree in a Science or Engineering discipline.
·  Preferably 2 years experience in the pharmaceutical industry in GMP regulated areas and 5 years or more for the role of the Senior QA Executive.

Technical

·  A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing.
·  A good working knowledge of Deviations, CAPA, change controls and Product Quality Review with hands-on experience will be preferred

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.

  

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.