Deviation CAPA Champion
GSK
Wavre, Brabant wallon Belgique
2 dagen geleden

Data de publication :

Job purpose :

The Deviation / CAPA Champion assures the overall quality and effectiveness of the deviation and CAPA process within a Manufacturing Performance Unit (MPU) / Support Performance Unit (SPU).

MPU / SPU will include QA & Operations.

You,

  • ensure best practices are in place and in use,
  • seek for continuous improvement, while ensuring application of the right level (risk-based approach) of quality,
  • assure capabilities buildup within the MPU / SPU through effective coaching, monitoring / reporting, and performance management.
  • Your responsibilities :

  • You are responsible for the effectiveness of the Deviation and CAPA processes (lean and efficient),
  • You are co-responsible with the MPU / SPU Head for the progressive reduction of deviations through adequate root cause analysis and implementation of effective CAPAs,
  • You provide overall deviation and CAPA content assessment through application of adequate methodologies, i.e. START (Quality evaluation grid).
  • Based on content assessment provide mentoring to ensure progressive capabilities build-up within the MPU / SPU,

  • You ensure certification and decertification process is in place and in use within the MPU / SPU for those managing deviations
  • You ensure adequate Key Performance Indicators and processes (i.e. tier meeting, deviation review board, ) are in place and in use to monitor, track, and drive progress with respect to i.
  • e. human errors, recurrent deviations, deviation overdue, CAPA overdue, CAPA efficiency and CAPA effectiveness checks,

  • You escalade risks, problems, proposing action plans to Leadership Management Team for decisions regarding deviations and CAPA,
  • You analyse, lead and coordinate coaching or mentoring based on individuals’ needs and business requirements, i.e. new standards, transversal procedure, etc.
  • You evaluate applicability of best practices (deviations and CAPA) within the MPU / SPU and provide pro-active feedback for their implementation and use,
  • You are the local operational expert of the deviation and CAPA process and act as a coach for deviation fronter during inspections,
  • You actively contribute to driving cultural change, building up of capabilities and continuous improvement within the MPU / SPU,
  • You actively benchmark local practices (not included in Best Practices package) with other MPU / SPU), activate the network to anticipate changes / trends.
  • Why you?

    Basic Qualifications :

    We are looking for professionals with the following required skills to achieve our goals (must-have) :

  • You hold a Master’s Degree in Sciences with Manufacturing and / or Quality orientation,
  • You have at least 5 years of relevant experience in roles including CAPA / deviations processes management, GMP systems management, training to teams on these processes and best practices,
  • You have a good understanding of regulatory guidance and cGMP / GQP / GQMP
  • You are driven and goal-oriented
  • You are a strong influencer (frequent interactions with Leadership Teams and Head of, etc.)
  • You show excellent communication skills (able to communicate with various audiences, networking, etc.)
  • You coach and mentor a team (alignment on best practices, knowledge sharing, assessment and feedback sessions to the team, etc.
  • You drive change and transformation
  • You are fluent in French and English both written and spoken.
  • Preferred Qualifications :

    The following characteristics are assets (nice-to-have) :

  • You have participated to Lean actions or organisation projects
  • Why GSK?

    Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

    Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

    For further information, please visit .

    Our department :

    Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most.

    Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So, it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.

    As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

    The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

    At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

    We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

    Si vous présentez un handicap et si vous avez besoin d' une assistance au cours du processus de sélection, vous pourrez nous informer de l'assistance dont vous avez besoin pour que nous prenions les dispositions nécessaires.

    Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique.

    Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable.

    Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients.

    Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.

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    L'obtention d'une autorisation écrite préalable est une condition préalable à tout accord (oral ou écrit) entre la société de recrutement / l'agence pour l'emploi et GSK.

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