Coordinator Project P&P - Change Control Management

工作内容

Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal.You commit to living our values and expectations and performing against our Innovation, Performance and Trustpriorities. In return, GSK commits to providing the right environment for you to thrive.Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a , we empower you to be yourself, share ideas and work collaboratively

Coordinator P&P

Job Purpose

Coordinate project and manage associated change control (eCC) for MPU LVV. Coordinate and operate some of the associated validation activities with the support of validation team of the MPU.

In this role you will…

• Be responsible for initiation, implementation, monitoring and closure of projects / eCC linked to the LVV Primary facilities and/or to transversal activities / projects
• Ensure implementation of the validation policies for the processes & equipment (Validation life-cyle process, Qualifications, Process Validation).
• Be responsible for assuring inspection readiness – regarding Change Management (eCC)
• Act as a key interlocutor for change control and project you own for the other department of the MPU (QA, TS, production, ...) or outside the MPU (QC, TLCM, SPU IM, ...)
• Act as the MPU representative in transversal and/or technical projects.
• Continuously anticipate potential improvements of current processes with assuring the compliance with existing standards.
• Define and implement adequate validation strategy in compliance with FDA, EMEA and International quality standards with support of validation team of the MPU.
  

This job opportunity is a permanent contract not opened for relocation.

Why you?

Qualifications & Skills

• University degree in Engineer in Chemistry, biochemistry, or agronomy or Pharmacist or equivalent through experience
• Knowledge of International standards (CFR and Eudralex), GMP and Regulatory
• Experience in aseptic processing, vaccine production, quality control or quality assurance is an asset
• Good knowledge in English, including presenting and negotiating.
  

Preferred Qualifications & Skills

• Good organizational skills
• Results oriented
• Proven ability to work cross-functional teams and projects to obtain desired business objectives
• Good analytical and problem-solving skills
• Strong communication skills. Proven ability to 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

Global Industrial Operations (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 Industrialization (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

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GSKTechTalent

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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