Purpose
To lead and support the site’s regulatory conformance activities, as well as maintain effective and compliant quality systems relating to self-inspection, audit management, quality risk management, management review and quality escalations.
Key Responsibilities Area
1.General
- Be the process owner to achieve compliance with regulations, QMS and company policies:
- Be the subject matter experts (SMEs) for the site.
- 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.
- 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.
2. Regulatory Compliance
- Serve as Single Point of Contact (SPOC) between the site and Global Regulatory Affairs (GRA) on regulatory compliance matters.
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
3. Audits and Self - Inspections
- Prepare and lead inspection readiness programmes for Independent Business Management (IBM) audits and above audits.
- Prepare the site external audits, lead the backroom staff during the audit, and coordinate sitewide inspection readiness activities.
- In partnership with key stakeholders, define site CAPAs timely in response to findings and track to closure.
- Ensure timely closure of audit related CAPAs, and extensions are escalated as appropriate.
- Own the site self-inspection process, and work with internal stakeholders to develop, publish and manage the annual self-inspection plan
4. Quality Risk Management (QRM)
- Own the quality risk management process and manage the process from risk identification to assessment, timely mitigation and closure.
- Prepare for QRM meetings, ensuring decisions and action logs are captured, and followed through during the QRM meetings.
- Ensure risks are escalated timely and as appropriate.
- Maintain and update quality risk register
5. Management Review – Site Quality Council
- Work with SLT to align KPIs to monitor for the year.
- Prepare for the SQC meetings, ensuring decisions and action logs are captured through the meeting minutes, and followed through during the SQC meetings.
6. Quality Escalations
- Support the Site Quality Escalation Process
7. Quality & Regulatory Intelligence (QRI)
- Serve as Single Point of Contact (SPOC) between the site and Global QRI team.
- Manage the QRI process to ensure that local impact assessment, if required, is completed timely
8. Biological Product Deviation Report (BPDR)
- Support the BPDR process, including the identification and assessment of triggers for BPDR and facilitation of BPDR writing and submission
- Compliance with BPDR requirements
9. Halal Product Assurance System (HPAS):
- If assigned, be the Halal Supervisor to manage and coordinate the Halal implementation for site.
- Determine correction and corrective action for HPAS.
- Counterpart for external body and Halal auditor.
- Member of the Halal Management Team.
10. EHS
- Comply with company requirements on EHS
11. Deputization
- For Senior QA executive, deputize N+1 responsibilities as required
Skills, Knowledge & Experience
Professional
- Minimum University Degree in a Science discipline
- Minimum 5 years experience as a QA Executive within the pharmaceutical industry
Technical
- Good understanding of cGMP regulatory and legal requirements as applied to quality assurance of vaccine manufacturing and product registration
- Experience in pharmaceutical manufacturing
- 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
Business
- 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
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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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