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Gsme in Cross Contamination Control Strategy

Il y a 3 mois

Wavre, Wallonie, Belgique GSK Temps plein

Site Name:
Belgium-Wavre

Posted Date:
May 2 2023

  • Job Description


The GSME has the task to deploy a risk-based Cross Contamination Control Strategy for all the Vaccines sites aiming to reduce product quality, patient safety and inspection exposure.

The GSME identifies the gaps existing site by site and define local and global action plan supporting the Cross Contamination Control strategy.

The job owner manages risks escalation to the different parts of GSK.

The job owner has the task to create and/or update the relevant internal standards (GQP, VSOP, GG etc.) related to Cross Contamination Control Strategy.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Monitor and assess new developments, industry trends, evolving regulatory expectations in area of expertise
  • Represent GSK in internal and external boards and contribute to the development of new standards
  • Representative for GSK Vaccines at QMS leveloMaintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative / new technologies, industry standards and registered risks pertaining to area of expertise
  • Define GSK vaccine requirements and sets policies and standards which are implemented through QMS, VSOPs, technical standards or other means (e.g. CAPA globalization, assess requirements and propose global/local actions to avoid reoccurrence)
  • Ensure compliance with external and internal requirements (e.g. GSK QMS, GSK Vx VSOPs) through interaction with internal organization
  • Support site in implementation of GSK Vaccine requirements and monitor site implementation status
  • Lead or Support projects and other activities (e.g. ownership of transversal risks) in R&D, Quality and GIO, partnerships and Joint Ventures
  • Provide expertise support (e.g. inspections preparation and response writing, risks, observations, deviations, improvement initiatives, remediation, CAPA globalization, Quality Alerts)
  • Development and delivery of training materials
  • Manage internal network(s) of local and global experts and ensure sharing of bestpractice and learnings in area of expertise
  • Manage and maintain relationship with GSK experts from other Business Units (e.g. Pharma (GSC))
  • Develop mid / long term vision and strategy within networkoSupport sites to assess need for escalation to QMT (if issue is applicable to other sites)
  • Mentor and coach local experts
  • Accountable to drive global vaccines strategy in area of expertise
  • Define GSK vaccines system / process mandatory standards in compliance with GSK QMS requirements
  • Deploy process throughout network and ensure standardization/harmonization at the appropriate level


 Monitoring
  • Accountable to collect and analyze assessment criteria on the system effectiveness and performance (incl. trend analysis) and report to senior management as well as to competencies in the network
  • Drive continuous improvementoOwn and maintain applicable global Vaccines procedure (e.g. VSOPs), tools, templates, and other documents
  • Own applicable libraires, repositories etc

_ Why you?_:

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • University Degree in engineering/scientific discipline
  • Good understanding of lean methodologies and principles
  • Risk Management / Project Management
  • Regulatory knowledge related to the specific expertise
  • Strong technical writing skills
  • Benchmarking skills
  • EHSawareness
  • Deviation management
  • Good level of written and spoken English (French is a plus)
  • Cross Contamination control Strategy, Contamination Control Strategy, Viral Safety Specialist, Cleaning Validation specialist

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Enable and drive changes, influence: HIGH
  • Leadership: HIGH
  • Develop people: HIGH
  • Multicultural mindset
  • Strategy and vision
  • Working across boundaries
  • Teamwork ability
  • Networking and facilitation skills
  • Coaching, mentoring, training
  • Problem solving attitude
  • Cando spirit
  • Customer focus
  • Able to propose solutions in critical situations
  • Prioritization skills
  • Execution & coordination skills in validation
  • Supplier interface
This role is based in Wavre but could be also based anywhere in Europe.

_ Why GSK?_:


We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics.

We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on