Manager QC Validation Computer Compliance project

工作内容

Site Name: Belgium-Wavre

Posted Date: Mar 14 2025

About The Role

The purpose of this role is to develop, review, approve and coordinate deliverables to release/modify/decommission laboratory equipment and computerized systems for regulated use while ensuring compliance with internal procedures and industry guidelines.

Be part of the BE QC Equipment & System validation organization.

Be accountable, organize and develop Team charge of the QC Validation Operations on Compliance Project (ALCOA ++ implementation). Together with the validation team, be accountable for the effective validation of Analytical computerized equipment.

The role requires agile and creative skills in order to match every quality and business constraints with Equipment Validation. He is accountable for the systematic approach to collecting and analyzing all the required data to give reasonable assurance and documented evidence that the processes and analytical methods will, when operated within specified parameters, consistently produce results within predetermined specifications. This includes Qualification (IQ), Operation Qualification (OQ), or Performance Qualification (PQ).

He/she ensures the adequate management of validation deviation and potentials CAPA

These activities are organized and delivered with the highest quality in accordance with cGLP’s and EHS requirements and by interacting efficiently with relevant internal partner (Support departments, QA, etc.)

In order to release commercial and non-commercial vaccine products, perform laboratory investigations during the development of new vaccine process, and improve & promote productivity, added value and cost control.

About The Responsibilities

• Responsible for the coordination of the validation for local QC projects with a Data compliance & security focus: establish VMP and take decisions during the validation (from DQ to VSR).
• Expert of ALCOA++ requirements implementation for system validation (GAMP5) - Responsible to establish & implement DI Mitigation or Remedial plan on Analytical Equipment
• Audit trail strategy deployment on computerized validated system, follow up and process rationalization.
• Analytical Technical Expert or Subject Matter Expert of validated software (e.g. : LabX, Tiamo, ZSXplorer)
• Improvement of Validation process, process rationalization
• System access request approval for all QC equipment
• Expert of Analytical Equipment implementation & validation on OT Network
• Responsible for the QC of continuous validation activities: put in place/maintain the validated status of system: establish and execute CVP, coordinate Change Control, deliver validation services including IQ/OQ and PQ support (writing and review/approval of protocols, execute, manage deviation and out of specification investigation).
• Manage a team of max 5 people including technician, coordinator & consultant/contractors’ resources.
• Develop validation expertise within his/her team in order to be recognized as single point of contact for site validation activities and expertise, acting as a SME (Subject Matter Expert)
• Support for ensuring inspection readiness regarding validation during internal GSK audits and external authority’s inspections and to assure follow-up related validation commitments.
• Participate in the evaluation of new standards: evaluate impact on local activities and integrate best practices.
• Allocate local support resources to global/major project to deploy in his department.
• Manage Deviation & CAPA linked to his/her activities
  

About You

• Master’s degree in Science or Engineering or qualification by experience in a similar role
• Be able to understand the characteristics of GMP relevant Analytical Computerized Equipment used for QC Physico-chemistry, Microbiology release, Incoming Materiel & Environmental Monitoring testing including their potential impact on product and patient safety.
• Expert in computer compliance standard (CFR, Eudralex, MHRA) data integrity ALCOA++ principle.
• Be able to use a risk-based approach for problem solving and prioritization of tasks
• Good interpersonal relationship skills
• Good oral and written communication skills in French & English
  

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 GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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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