This is a one-year contract position.
Are you looking for a quality compliance role where you can enhance your project management expertise in a state of the art manufacturing environment? If so, this Quality Executive role could be an exciting opportunity to explore.
As a Quality Executive, you will be supporting Quality Manager in all Quality Management Systems in Morocco & Tunisia.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Key Responsibilities:
- Support QM to implement all actions issued from Annual Quality Plan related to LOC Morocco within the relevant timescales
- Provide Quality metrics related to LOC Morocco activities Provide all data needed for annual management review regarding Morocco Support QM for the organization of Quality Council.
- Ensure that all Morocco SOPs are in place, in use & effective, updated & training has been conducted across the business Processes in place for delivering routine training for updates to SOPs, GQPs, and as relevant.
- Ensure that quality documentation management process in Morocco is in place, in use & effective according to quality documentation management process. Ensure effectiveness of the documentation and data management system(s) review in Morocco.
- Verify IQA & QA and liaise with manufacturing sites to ensure compliance to local registered technical details. Liaise with External Supply Quality for products that are manufactured by local contractors to Ensure compliance to local registered technical details Approval in CDMS.
- Follow up of Change Control progress in VQMS initiate change control relating to quality for Morocco & Tunisia.
- Support QM to Assess the scope of the Quality Alert and determine if it is applicable before accepting or declining a Quality Alert in the Quality Alerts hub Develop CAPA to address the issue and prevent recurrence. Communicate the process for effectiveness to the Quality Manager.
- Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks. Attend Morocco RMCB meeting Escalate to Quality Manager any potential Quality risk identified and related to Morocco activities.
- Ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by either LOC Quality or the appropriate Central Team (e.g. ESA). Perform audits according to annual schedule
- Prepare MM universe. Prepare the annual audit schedule Perform self-inspection according to annual schedule Track CAPAs in VQMS.
- Contact Quality audit for LOC Morocco, Support Quality Manager to manage any audits groups, MoH inspections, others,….
- Ensure CAPAs generated by different quality systems in Morocco are maintained through VQMS, ensure escalating appropriately and on time Demonstrate that LOC Morocco effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
- Support QM to Manage LIC/PIRC process in Morocco LOC & Tunisia with related training.
- Provide guidance on the deviation classification and review remedial actions taken. Raise deviation owned by quality in VQMS Confirm the initial assessment of the deviation, including severity and any escalation requirements. Provide guidance on the scale of the root cause investigation required. Identify Corrective and Preventive Action Review the deviation record, and confirm the classification, once all the required information has been documented. Monitor local area periodic trend reviews of deviations, including assessment of effectiveness of action taken.
- Morocco complaint process management. Follow up on product complaints received in Morocco with supplier sites, customers and commercial teams. Verification of investigation reports & conclusion Perform annual complaints trend. Communicate to NSC the monthly Reconciliation of Product Complaints/ADRs Report.
- Ensure appropriate documentation to perform repacking operations. Oversight repacking operations within local contractors
- 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. Establish Quality Training Annual Plan Share the Quality Training Annual Plan with leadership team. Perform Quality training according to annual plan.
- Attend & participate in Regional Quality Council. Prepare, update and provide data needed for Regional Quality Council.
- Attend & participate in the weekly meeting providing Morocco & Tunisia updates to the EMC Quality team.
- Collects & provide to Quality & EMC Quality the Morocco KPI .
- Assess the temperature excursion & impact Manage & communicate VDCF form & process (Notify supply site if temperature excursion not covered by thermostability data) Decide & communicate temperature excursions & impact Manage Temperature records received from Third parts.
- Support CS&L team to draft and update DRA for Morocco Identify potential risks impacting GSK products distribution in Morocco and escalate any risk to Quality Manager & EMC Quality Ensure that mitigation plan is implemented
- Support distributors quality team in order to be comply with GSK requirements
- Track CAPAs implementation of all CAPAs issued by external supply audits and LOC quality Audits in VQMS
- Support QM to Perform audits regarding warehousing & distribution activities Track CAPAs implementation in VQM
- Verification and approval with the QP Quality Agreement in Morocco from Quality perspective, Ensure & monitor appropriate KPIs.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree
- 3 - 5 Years of experience in similar QA roles
- Pharmaceutical experience background is highly preferred.
- Experience with quality processes and activities
- Good command of English.
Post Closure Date:
27 November 2024
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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