Operational QA Specialist Logistics Distribution

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**Operational QA Specialist Logistics Distribution Center**:
**Job purpose**:
As a **Operational QA Specialist Logistics Distribution Center**, you will ensure regulatory and GSK QMS vaccines requirements are implemented and followed at GSK and at our logistics partner.

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**In this role you will **
- Work closely with Logistics partner personnel and GSK staff in Gembloux to ensure continuous supply of vaccines in compliance with GMP/GDP regulations and GSK QMS vaccines quality requirements:

- Support quality aspect of inbound movement of the vaccine (Quality Oversight of the received stock at the logistics partner, ensuring that the operation at our Logistics partner meets GSK quality requirements).
- Ensure Quality Oversight of the Logistics partner related processes (inbound, validation, maintenance, calibration, cleaning, pest control, etc.) and ensure related documents are reviewed, handled, and approved in accordance with procedures and in a timely manner.
- Ensure requirements from the quality agreement are respected and contribute to the Quality Agreement lifecycle management.
- Ensure our logistics partner’s Quality System for services provided to GSK is in compliance with relevant regulations and GSK QMS requirements/processes.
- Act as QA authority for deviations, CAPAs, change controls and other GSK QMS processes as applicable that are related to our logistics partner operations, following relevant procedures, ensuring that all issues are escalated appropriately, proper actions are defined, and quality impact is properly assessed.
- Ensure GMP/GDP training is deployed and completed.
- Ensure periodic GSK GMP/GDP audit is performed at our logistics partner in collaboration with other GSK stakeholders. Ensure a self-inspection planning is in place and adherence to the plan is respected.
- Act as QA reviewer of GSK and our partner SOPs, ensuring compliance with GSK QMS processes and requirements, ensuring comments are discussed and implemented before approval by the Responsible Person.
- Implement and monitor quality KPIs for our partner activities in collaboration with its personnel and GSK staff. Preparation and lead GSK monthly quality governance meeting (Quality Council) and be part of our Logistics partner monthly quality meeting. Perform periodic review and ensure that negative trends are properly escalated to the GSK Quality Responsible Person. Ensure a continuous quality and compliance improvement mindset within our logistics partner and across other GSK distribution centers and stakeholders by collaborating and aligning on best practices.
- Ensure regulatory inspection readiness of our logistics partner; be involved as applicable to support during regulatory inspections. Proactively identify any potential quality, regulatory and compliance risks related to our logistics partner, managed via GSK system, actively work on mitigation plan and escalate in a timely manner any concerns to management.
- Perform the product quality reviews according to relevant procedures and in a timely manner. Monitor the implementation of the actions resulting from to the product quality reviews as applicable

**Why you?**
- Qualifications & Skills_
- Bachelor or Master degree in Sciences, Engineering, Pharmacy, Bioengineer or equivalent by experience
- Previous experience in a pharmaceutical /biological production environment, ideally in Quality or developing a Quality mindset.
- Direct experience with GMP/GDP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit).
- In depth knowledge of regulations, guidance, and industry standards related to the systems (e.g. WHO, PDA, ASTM, ISPE, PhRMA, IATA, GAMP, etc.)
- Good knowledge and expertise of quality systems, e.g. Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Risk Management, Validation.
- Good to Excellent English & French knowledge, written and spoken
- Preferred Qualifications & Skills: _
- Demonstrated impact and influence.
- Analytical mindset and autonomous
- Team player, good communication, open minded and patient focus
- Excellent organizational skills and attention to details.
- Demonstrate a serious commitment to accuracy, integrity, and quality while meeting goals and deadlines
- Strong technical and quality knowledge of distribution related technologies and technical services processes such as validation, maintenance, calibration, and measurement.

LI-Hybrid

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

**Why GSK?**

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

GSK is a global biopharma company with a spe