Purpose

To support the site’s regulatory conformance activities, as well as maintain effective and compliant quality systems relating to self-inspections, audit management, quality risk management, management review and quality escalations.

Key Responsibilities

• Serve as Single Point of Contact (SPOC) between the site and Global Regulatory Affairs (GRA) on regulatory compliance matters for the assigned product variation / submission.
• Support file submission efforts in close coordination with GRA and internal stakeholders.
• Support GRA and the site in providing responses to questions from Health Authorities (HA), supported by the relevant data package where necessary.
• Assess the potential regulatory impact of changes proposed by the site, and work with GRA to formulate and execute the submission strategy where necessary.
• Assess the potential regulatory impact of deviations
• Support inspection readiness programmes for Independent Business Monitoring (IBM) and above audits
• Prepare the site external audits, support the backroom staff during the audit, and coordinate sitewide inspection readiness activities
• Own the site self-inspection process, and work with internal stakeholders to develop, publish and manage the annual self-inspection plan.
• In partnership with key stakeholders, define site CAPAs timely in response to findings and track to closure and ensure timely closure of CAPAs, and extensions are escalated as appropriate.
• Serve as Single Point of Contact (SPOC) between the site and Global Quality & Regulatory Intelligence (QRI) team.
• Support the management of the QRI process to ensure that local impact assessment, if required, is completed timely.
• Prepare for and manage the Site Quality Council (SQC) meetings, ensuring decisions and action logs are captured through the meeting minutes, and followed through during the SQC meetings.
• Support the quality risk management process and manage the process from risk identification to assessment, timely mitigation and closure.
• Support the management of the Site Quality Escalation Process
• 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
• Perform gap assessments between local procedures and above-site documents, such as Vaccines SOPs (VSOPs) and QMS

Skills, Knowledge & Experience

• Minimum a university degree, in a relevant scientific discipline
• Minimum 3 years of experience in pharmaceutical industry.
• Experience in pharmaceutical manufacturing
• Good understanding of cGMP regulatory and legal requirements as applied to quality assurance of vaccine manufacturing and product registration.
• Knowledge of both the technical and regulatory aspects of the information included in the registration dossier is crucial to ensure the alignment between internal practices and the registered information
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Ability to create and maintain networks and build relationships transversally across the GSK network.
• The job holder will be instrumental in ensuring the preparation and the approval of registration dossiers that are aligned with shop floor practices

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore 

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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