Product and process validation specialist

Job content

Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer. We realise 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. These are 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 Trust priorities. 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 modern employer (https://www.youtube.com/watch?v=rPwvBGEXKsY) , we empower you to be yourself, share ideas and work collaboratively.

Product and process validation specialist

In This Role You Will

• Deliver the continuous validation activities and eCC validation for MPU LVV (Live viral vaccine)
• Define, coordinate and execute an adequate validation strategy with QA, in compliance with GSK quality standards.
• Write and/or Review the validation documentation regarding the GMP requirements and the GSK Vaccines procedures (Protocols, Reports, Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review ….).
• Ensure correct and state of the art validation approaches for change controls from Design Qualification step to the establishment of the Validation Summary report (which is final approved by the QA). This accountability involves knowledge of the Specific Validation Strategies (i.e.Homogeneity validation, Aseptic Media Simulation…).
• Manage deviations that occurs during validation or deviations impacting validated status: bring expertise and help in investigating and solving issues and associated CAPA.
• Responsible for assuring inspection readiness – regarding Validation – by Corporate GSK functions and RA authorities (FDE, EMEA, Canada).
• Responsible for participating, for validation presentation, in external and internal inspections (L2, L3, L4 audit)
• Ensure the compliance on EHS topics in/outside his area and develop the EHS mindset within his team and peers.
  

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

Why you?

Qualifications & Skills

• University degree in Engineer in biochemistry, biology or agronomy or Pharmacist
• At least 2 years’ experience in a pharmaceutical environment
• A first experience in validation/ QA validation is a requirement
• Experience in process validation (Homogeneity, EM PQ, UF Lifetime, Media buffer hold time) is a must.
• French fluent and professional basic writing and speaking in English is a requirement
  

Preferred Qualifications & Skills

• Good organizational skills
• Proven ability to work cross-functional teams and projects to obtain desired business objectives
• Good problem-solving skills
• Strong communication skills. Proven ability to communicate effectively with different departments
• Knowledge of vaccines and/or immunology process and products (manufacturing) is a must.
• Li-GSK
  

GSKTechTalent

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 .

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.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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