Specialist QA Validation

Job description

Site Name: Belgium-Wavre
Posted Date: Mar 14 2024

Specialist QA validation projects PA/IPV

Job Purpose

• Drive the QA Validation oversight for projects and some routine activities, as part of the GSK Vaccines network through the application of key business and GMP processes in line with the strategies, policies and standards of GSK Vaccines
• Built a strong partnership with the MU stakeholders in Validation/Process, Projects and external partners outside MU (central and global functions)
• Ensure regulatory compliance and audit readiness of the MU in scope and defend the validation approaches and decisions during internal and external audits with Validation partners

In this role you will...

• Be the dedicated quality partner for validation activities
• Participate in validation planning and project meetings
• Participate to the definition of the validation strategy for various projects
• Review and Approve validation documentation (projects and routine) in a timely manner
• Ensure adequate oversight of validation activities on the floor
• Participate to and challenge investigations related to the validation activities
• Be an active participant of the process and technical improvements in the unit, and simplifications
• Ensure timely escalation to Management of critical issues during validation, or impacting the validated status
• Pro-actively identify potential quality and compliance risks and manage these risks trough the project meetings and escalation process
• Ensure QA representation and decision making in all meetings related to his/her area of responsibility
• Acts as front-line spokesperson or QA representation during inspections/audits for validation activities
• Ensure compliance with GSK Vaccines standards policies, procedures and local regulations

Why you?

Qualifications & Skills:

• University degree (Biotechnology, Agronomy, Chemistry, Pharmacy or Engineer)
• At least 5 years professional experience in pharmaceutical environment, in quality and validation environment
• Good oral and written communication skills
• French is mandatory
• Good Knowledge of GMP Regulated environment related to validation activities.
• Good interpersonal relationship skills
• Problem solving and solution-oriented mindset

Preferred Qualifications & Skills:

• Agility to adapt to various projects/equipment/environments
• Good oral and written communication skills in English
• A knowledge of different regulations and standards related to validation activities
• To be a good team player in order to success in each validation project
• Able to take decision under pressure conditions
• Good knowledge of equipment processes
• Proactive and ready to take the lead to make things happen
• Ability to work under pressure on multiple deliverables within project time lines

*Li-GSK

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.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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