Manager Product & Process

Job content

Site Name: Belgium-Wavre

Posted Date: Nov 8 2021

We are looking to recruit a Project Manager Product & Process, for the MPU (Manufacturing Production Unit) New IPV (Polio Vaccines)

Your Responsibilities

• You are responsible for the coordination of the validation of projects linked to Primary environment related to equipment or process control/automation equipment.
• You define and implement adequate validation strategy in compliance with FDA ( Food & Drug Administration), EMEA and International quality standards.
• You ensure and coordinate the support (planning, weekly validation, resources, cost) to RPCs or projects
• You are responsible for VMP (Validation Master Plan)
• You review and approve protocols and certificates for IQ/OQ/PQ and check-lists
• You manage deviations and out of specifications: bring expertise and help in investigating and solving issues
• You ensure correct and state of the art Validation approaches for RPC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the Quality Assurance). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…)
• You participate as expert in external authorities inspections (EMEA, FDA, WHO…)
• You are responsible for assuring inspection readiness – regarding Validation – by Corporate GSK functions and Regulatory Affair authorities.
• You ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…)
  

Why you?

Basic Qualifications

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

• You hold a university degree in Engineering, Chemistry, biochemistry, or agronomy or PharmacistYou have knowledge of International standards (CFR and Eudralex), GMP and Regulatory
• You have at least 3 years’ experience in aseptic processing, vaccine production, quality control or quality assurance.
• You have a first experience in a matrix organization is an asset
• You demonstrate good organizational skills
• You are results oriented
• You have proven ability to work cross-functional teams and projects to obtain desired business objectives
• You show good analytical and problem-solving skills
• You a strong communicator and can communicate effectively with different departments
  

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.

GSK Vaccines – 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 www.gsk.com.

Our Department

GIO

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.

• Li-GSK
  

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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