Specialist, Validation and Sterility Assurance QA

仕事内容

Site Name: Belgium-Wavre

Posted Date: May 3 2023

Specialist, Validation & Sterility Assurance QA

The QA TS/Validation department is responsible for ensuring overall quality standards are met for products. Responsible for programmes to establish and maintain quality standards of existing products and services, as well as developing programmes to focus employees on quality improvement. Approval of batch release to the market

Develops and implements programs to establish and maintain quality standards of existing products, and internal systems and processes. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.

Your responsibilities:

Your responsibilities of the QA Validation & Sterility Assurance Specialist are among others:

• You define validation and risk assessment strategies for sterility assurance topics (such as aseptic process simulation and environmental monitoring)
• You challenge, review, and approve qualification and validation (IQ, OQ, PQ, PV, TCD, PVR) documentation, ensure compliance to quality standards and procedures.
• You write validation (VP, PQ, PV, VSR, PVMP, PVR) documentation according to quality standards and procedures.
• You ensure adequate oversight and follow-up on the validation and sterility assurance deviations & CAPA
• You ensure adequate impact assessment for change control processes
• You support the Product & Process, Production, QA Operations, and sterility assurance manager, and build a strong partnership with these stakeholders.
• You are the spokesperson during internal and external inspections for your subjects of expertise and areas of responsibility
• You drive implementation of commitments towards internal and external authorities
• You promote, identify, and drive continuous improvement mindset and initiatives using operational excellence tools
• You ensure EHS compliance and resolve/escalate EHS risks and issues
  
  

Why you?

Basic Qualifications:

• Master’s degree in an engineering or science discipline (biotechnology, agronomy, chemistry, pharmacy)
• Previous experience in sterility assurance and validation (3-5 years) and knowledge of cGMP and quality systems
• Minimum 5 years’ experience in an aseptic/laboratory environment, industry, quality, production
• Knowledge in technologies, closed system, production equipment’s, Utilities & Facilities Solution-oriented, proposal-driven and negotiating skills, critical thinking
• Professional fluency in English and French
  
  

Preferred Qualifications:

• Previous experience in GMP operational roles (such as operations, operational quality, MSAT, logistics) & knowledge of aseptic environments
• Demonstrated problem solving and decision-making capabilities
• Strong communication and influencing skills
• Ability to prioritise, manage workload, and escalate issues
• Proactively manage personal development (knowledge and skills)
• Knowledge of attenuated viral processes is a plus
• Advanced knowledge of aseptic, closed systems, utilities & facilities technologies
  
  

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

• 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.

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 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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