As a Quality Executive, you will Provide effective and efficient quality assurance systems support to LOC Quality Manager / LOC Saudi Arabia, including supporting in the implementation and maintenance of the QMS and as directed by the LOC Quality Manager KSA and meet the compliance standards of QMS and the local Regulator(s).
performs the day-to-day work to ensure that the quality systems required by the Saudi LOC element of the Supply Chain and Marketing Company Saudi Arabia are performed in a lean and efficient way.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Key Responsibilities:
Quality Strategy:
- Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
- Gain an understanding of the Supply Chain and Commercial Business and regulatory requirements including QMS requirement at a high as they potentially link to day to day and quality and regulatory improvement activities.
- Act as the relevant KSA quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on QMS compliance status, local regulatory requirements and updates on quality and plans and escalation of issues. Share learning and issues appropriately with other LOCs and regional colleagues.
Quality Systems:
- Supporting the Quality Manager KSA to ensure a robust, sustainability and effective of local regulations and QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC GSK element of the Supply Chain and KSA Marketing Company
- Support the implementation and maintenance of effective regulations and Quality Assurance systems to ensure that local regulations and operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements by supporting the KSA Quality Manager as directed to:
- Ensure that updated procedures are in place, for compliance of GSK standards and regulatory requirements & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to GSK standards.
- Promote local regulations and QMS management principles and seek continuous improvement of the processes
- Review, conduct impact assessments and implement any updates to regulatory requirements and GSK QMS policies where required.
- Manage local regulations and QMs management meetings according to GSK standards and Local regulatory requirements.
- Identify, Implement and Manage Objectives & KPIs where required
- Establish and manage Plans as per requirements
- Support the LOC Quality Manager - KSA to ensure that all internal procedures and systems in use in the LOC are compliant to and local regulatory requirements, and GSK QMS, Guide for Commercial Companies, including (but not limited to)
Further Quality activities to be assigned directly to perform, i.e:
- All CAPAs of KSA follow-up to ensure timely completion (prior to due date) - No overdue
- Responsible for change control and NPI change controls and ensure CC actions are aligned in Veeva system and completion of CC actins on time.
- LOC Quality Council – support the LOC Quality Manager – KSA re organizing Council meeting with regular meetings. This support should ensure that the Quality Council format, frequency and reporting are standardized to GSK global requirements.
- To be responsible for IQA / DRA / QA updates.
- LIC secretary to support Quality Manager as and when required.
- GQSOPs / PGSOPs review and update (to be assigned as related activities)
- Participate in Repacking / stickering process activities and ensure compliance with GSK standard requirement and all documentation are compiled as per standard requirements.
- Batch second review before final release of all imported batches
- Involve in SAP process as back up and also to perform task for batch creation and maintenance.
- Involve and responsible for Distribution Risk assessment review.
- Involve in IBM / 3rd party audit process to support Quality Manager.
- Quality Executive backup during absence / vacation period.
- Involve in Deviation process as and when required.
- Assist LOC Quality Manager as when required.
- To be involved in projects ( if any ) to perform and complete and also to support Quality Manager
Why you?
Basic Qualifications:
We are looking for professionals with the required skills to achieve our goals:
- Minimum 2 years’ experience.
- Pharmaceutical or science degree is mandatory.
- Fluency in spoken English is a must.
- Understanding of and experience in quality assurance systems particularly in the areas of batch release, product complaints / incidents, artwork control and performing audits
- knowledge of regulatory requirements pertaining to GMP/GDP
- Knowledge on effective quality documentation systems
- Professional written and verbal communication skills.
- Ability to deliver clear communications and foster excellent working relationships with peers and management.
- Analytical mind, good attention to detail and problem-solving skills within a structured process.
- Good team player – works well in cross-functional teams
- Ability to multi-task and work under pressure
- Concise in the description of the different QA situations. Able to stick to the standard and not be pressurized.
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
- Flexible thinking – able to challenge and see views from different perspectives
- Ability to self-motivate and be resilient and focused under pressure
- Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
- Knowledge and usage of Veeva quality Management system.
- Pharmaceutical product knowledge.
- Previous experience in manufacturing site.
- KSA Driver’s License (preferable).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Knowledge and usage of Veeva quality Management system.
- Pharmaceutical product knowledge.
- Previous experience in manufacturing sites.
Closing date:
04/03/2025
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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