QA Validation Specialist

작업 내용

Site Name: Belgium-Wavre

Posted Date: Dec 19 2022

Are you looking for a QA validation role in the challenging Manufacturing & Logistics environment? Would you like to join a team of 6 persons doing the validation & technical services for Packaging & Warehouse activities? If so, this opportunity could be the perfect fit for your career!

Ensuring and supporting oversight & QA activities on the validation of automated and computerised systems used across Packaging, Warehouse & Visual inspection (MPU VI PW) operations at Wavre.

Together, within a dynamic team of 6 colleagues, as the quality interface, you support the Product & Process team with projects linked to the Packaging, Warehouse & Visual inspection.

QA Validation Specialist

In this role you will…

• Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerised systems, & equipments:
• Writing, reviewing and approving of Validation Plans (VP)
• Writing, reviewing and approving of Validation Summary Reports (VSR)
• Reviewing and approving of design documentation (TCD, ERES, SRA, URS, DQ, ...)
• Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
• Writing and reviewing of Periodic Review Reports (PVR)
• Reviewing and approving of CSV specific documentation (inventory, ...)
• Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to validated systems & equipments linked to Packaging, Warehouse & Visual inspection..
• You manage the workload related to his area of responsibility (project, engineering, maintenance & automation teams, cluster, ...) as required by MPU priorities.
• You support the team and management during internal and external audits
• You ensure the local QA CSV activities in order to increase the service level.
  
  

This job opportunity is a permanent contract, based in Belgium.

Why you?

Qualifications & Skills:

• Minimum Bachelor’s degree with relevant experience in the field or Master’s degree, specialization in Automation, Engineering Sciences
• Minimum 3 years’ experience in validation
• Knowledge in computer systems validation role in a pharmaceutical environment.
• Specific Knowledge required:
• CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
• Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
• Deep understanding of validation principles within GSK
• Fluent in French & English
  
  

Preferred Qualifications & Skills:

• Critical mind
• Problem solving mindset and ability to work in partnership with your team and stakeholder
• Ability to make independent decisions even under pressure, ability to adapt, work under uncertainty and accommodate flexible work demands.
• Strong interpersonal skills with demonstrated ability to engage, empower and influence people
  
  

Why GSK?

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 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.

Find out more:

Annual Report 2021

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 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 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.