Are you aQuality Executive Gulfwho is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If soQuality Executive Gulfrole is the one for you to explore.
As aQuality Executive Gulf,you willProvides effective and efficient quality assurance systems support to the LOC Quality Lead-Gulf, including supporting the implementation and maintenance of the QMS and as directed by the LOC Quality Lead-Gulf, performs the day to day work to ensure that the quality systems required by the Gulf LOC element of the Supply Chain and Marketing Company Gulf are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator(s)
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Core Responsibilities:
Quality Strategy:
Maximize performance of team through regular coaching sessions
Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
Act as the relevant Gulf quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning’s and issues appropriately with other LOCs and regional colleagues.
Gain an understanding of the Supply Chain and Commercial Business and Quality Plans at a high as they potentially link to day to day and quality improvement activities.
Quality Systems
Supporting the LOC Quality Lead-Gulf to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC element of the Supply Chain and Gulf Marketing Company.
Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies ,GMP, GDP and regulatory requirements by supporting the LOC Quality Lead-Gulf as directed to:
Ensure that all SOPs are in place, updated & 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 SOPs, GQPs, and GQMPs as relevant.
Promote QMS management principles and seek continuous improvement of the processes
Review, conduct impact assessments and implement any updates to QMS policies
Manage QMS Management Review meetings according to local SOPs
Identify, Implement and Manage QA Objectives & KPIs
Establish and manage Annual Quality Plans
Support the LOC Quality Lead-Gulf to ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to)
LOC Quality Council – support the LOC Quality Lead-Gulf re organizing Council meeting with regular meetings. This support should ensure that the Quality Council format, frequency and reporting are standardized to global requirements. In addition support should be provided re Quality metrics and reporting format/ system in place.
Change Control - perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.
Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct rootcause analysis to investigate deviations and develop CAPA’s. Local process in place to track and review CAPA plans on routine basis. Demonstrate that Gulf effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
Auditing - perform day to day work to support the local process that is in place for MM and IBM auditing. Work with the LOC Quality Lead-Gulf to ensure:
The MM and IBM auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management.
MM and IBM audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
There is a process in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by Gulf QA Team or the appropriate Central Team (e.g. ESA). e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers.
Availability if requested to participate in MM and IBM audits with the agreement of the relevant Central Team.
The commercial element of the Supply Chain and the Quality elements of the Marketing Company are audit ready.
Complaints - perform day to day work to support an effective complaints management process ensuring:
the assessment of potential issues aredetermine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate.
report and follow up on product complaints with manufacturing sites, customers and commercial teams.
Incident management – Support the LOC Quality Lead-Gulf to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global PIRC process. Assist the LOC Quality Lead-Gulf in any investigations triggered by local incidents and in conducting Local Incident Committees (LICs).
Product supply - performs day to day work to supportsystems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements:
responsible for the review and at the direction of the LOC Quality Lead-Gulf the approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.
Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details.
Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
Support the LOC Quality Lead-Gulf with communication to the GMS supplying sites, R&D and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied.
Artwork management - perform oversight of Artwork Control Procedure
Local Repacking – perform day to day work to supportrepacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples.
Third Party Oversight (MMW, 3PL and Distributor)
To perform MMW oversight and ensure key process are in place at MMW. Having regular meeting to discuss Quality KPIs and Quality CAPAs
To ensure QualityKPIs from Distributors are frequentlymonitored.
Others
Acts in the role LOC Quality Lead-Gulf in the absence of the LOC Quality Lead-Gulf.
Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with GSK policies.
Ensures all product specifications and related documents (e.g.CoAs, TTS, IQA) are maintained compliant to current registered details.
Maintains and updates the QA Standard Operating Procedures.
Why you?
Job Qualifications:
We are looking for professionals with these 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 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
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 site.
UAE Driver’s License.
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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