Computer System Validation Manager
il y a 2 jours
**Site Name**: Belgium-Wavre
**Posted Date**: Dec 26 2024
Job Purpose
The “Computerized System Validation” Manager will be responsible for managing CSV activities (outsourced workers through FSP) who delivers fit-for-purpose Computerized System Validation activities.
The incumbent will lead the team, continuously assess and adapt where/when needed the ways-of-working to ensure that the team provides and stay compliant with internal Policies, procedures and external Regulations (e.g., 21 CFR part 11, EMA Annex 4) within GSK Vaccines QC & R&D Operations Belgium.
The manager will also work in partnership with a broad range of stakeholder groups such as CSV manager R&D ,Quality, Tech, Data Reduction, Data Management, SPOC DI, Integration Equipment Validation, Procurement and business to proactively define standards, identify cost saving opportunities and accelerate generation of scientific results.
Key Responsibilities
- Implement the new EUA/DRS life cycle mgt process in QC SOP (9*43224)
- Deliver fit-for-purpose Computerized Systems validation to our QC customers
- Develop and maintain validation templates
- Ensure CSV Readiness and act as Subject Matter Expert (SME) for Computerized Systems Validation topics during audits and Regulatory inspections
- Manage Functional Service Provider (FSP) platform to deliver projects and give support with respect of Quality, priorities received and allocated budget
- Establish metrics and Key Performance Indicators (KPIs) to identify challenges, opportunities and implement continuous improvement changes
- Deliver training, coaching and mentoring on CSV matter
- Ensure compliance to applicable Data Integrity requirements
- Support the introduction of new technologies/platforms and new ways of working (e.g., Agile, CSA,)
- Seek for synergies with R&D colleagues
**_ Why you?_**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- University degree preferably with a scientific orientation or equivalent by experience
- At least 5 years of experience in a pharmaceutical or regulated QC/R&D environment, with a focus on delivering fit-for-purpose solutions
- At least 3 years of experience in managing a team (prioritization, resource mgmt., budget control)
- At least 5 years of experience in performance, risk and quality management; including risk mitigation planning and tracking, milestones and actions management
- At least 5 years of CSV interaction experiences with GSK Vx international sites
**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:
- Master’s degree in Computer Sciences or Engineering and MBA.
- Minimum 5 years’ experience leading a large team of validation specialists
- Broad knowledge on infrastructure systems, equipment design and validation, maintenance and project management
- Good interpersonal and influencing skills allowing to interact at all levels of the organization, including senior management and to influence and lead without hierarchical authority
- Good knowledge of data integrity & CSV international standards
- Demonstrated ability to handle several projects in different stages at the same time, using initiative and imagination to meet agreed objectives and timelines
- Good skills in English
Li-GSK
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.
**Important notice to Employment businesses/ Agencies
-
Validation Consultant
il y a 7 jours
Wavre, Belgique Adiutum SA Temps pleinAre you passionate about Life Sciences and IT? Computer System Validation might be perfect for you! We are looking for a CSV Consultant (M/F/x) to join our fast-growing team of talented and motivated consultants! A CSV consultant will use his/her knowledge of cGMP and related regulations and guidelines, and specific knowledge of computer validation...
-
Specialist QA Validation
il y a 3 jours
Wavre, Belgique GSK Temps plein**_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...
-
Validation - Senior
il y a 4 jours
Wavre, Belgique Jefferson Wells Temps pleinLocation: **Wavre** **#24060** **Validation - Senior** **Contracting - Brabant Wallon** **Your responsibilities **?** The mission consists of: - Ensuring quality for the validation part in the relevant projects (e.g., PUPSIT, RTU,) - Conducting QA Oversight of validation activities - Actively participating in defining validation strategies in...
-
QA Validation Officer
il y a 1 semaine
Wavre, Belgique HAYS Temps pleinPharma - QA - Assurance qualité - Validation | 1095623 **QA Validation Officer - Brabant Wallon** Pour l’un de nos clients, une société pharmaceutique située dans le Brabant Wallon, nous sommes à la recherche d’un QA Validation. **Tâches**: - Gestion du plan de qualification et validation des installations et des systèmes - Approbation des...
-
Incoming Material Validation Support
il y a 15 heures
Wavre, Belgique Jefferson Wells Temps pleinLocation: **Wavre** - Type: **Contracting** **#20747** **Incoming Material Validation Support**: Walloon Brabant - Contracting Our partner is looking for a **Incoming Material Validation Support** to join its team. This international company is well-known for its** pharmaceuticals and vaccines**. **What are your responsibilities?**: - Manage the...
-
Validation Senior
il y a 4 jours
Wavre, Belgique amaris Temps pleinJob description Job description Join our team and start a new adventure in an international and dynamic environment where you will fulfill your career aspirations in a fast-growing organization. Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in the biopharmaceutical industry while acting as an...
-
Validation Senior
il y a 3 jours
Wavre, Belgique Amaris Consulting Temps plein**Job description**: **Job description** Join our team and start a new adventure in an international and dynamic environment where you will fulfill your career aspirations in a fast-growing organization. Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in the biopharmaceutical industry while acting as...
-
Analytical Methods Validation Bio
il y a 2 jours
Wavre, Belgique Jefferson Wells Temps pleinLocation: **Wavre** **#24072** **Analytical Methods Validation Bio** **About our client** The new Global Quality (GQC&PQ) organization have the goal to bring innovation, integrated capabilities, and speed to our customers through an empowered team that deliver results and enable network success. Within GQCPQ, the Global Quality & innovation team drives...
-
Wavre, Belgique GSK Temps plein**Site Name**: Belgium-Wavre **Posted Date**: Jan 15 2025 **Aidez-nous à devancer la maladie en participant à notre programme de stages**: **Formation requise**: Vous êtes étudiant(e) en Bachelier/Master en Administration, Secrétariat, Informatique, Digitalisation ou domaine similaire dans un établissement d’enseignement européen. **Langue**: Vous...
-
Product and Process Validation Specialist
il y a 15 heures
Wavre, Belgique GSK Temps plein**_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...
-
Fp&a Manager
il y a 7 jours
Wavre, Belgique ABBVIE Temps plein**Job purpose & objectives: Your role at AbbVie** The FP&A Manager is the leader and owner of the Financial Planning and Analysis (FP&A) cycles within Belgium Commercial affiliate. In this role you are responsible for the planning, consolidation, validation, chasing and challenging of all input required for the various FP&A cycles. You have the main...
-
Coordinateur Projet de Systèmes Automatisés
il y a 2 jours
Wavre, Belgique Activa Temps plein**Description**: Dans le cadre des activités de son département EIAD, nous recherchons pour notre client un coordinateur projet. Il sera responsable du suivi de projet de systèmes automatisés et du bien déroulement de ceux-ci, en milieu pharmaceutique (GSK Wavre). - Vous intégrez une équipe d’automaticiens et d’informaticiens - Vous travaillez sur...
-
QA Em-v Manager
il y a 5 jours
Wavre, Belgique GSK Temps plein**_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...
-
Manager, Analytical Harmonization and Modernization
il y a 7 jours
Wavre, Belgique GSK Temps plein**_Be You’ at GSK !_** At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realize 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...
-
IT Project Coordinator
il y a 4 jours
Wavre, Belgique CTG Temps plein**Regulatory Compliance**Brussels**: Sylvain Marsal Recruiter **IT Project Coordinator**: We are currently looking for a talented** IT Project Coordinator **to join our team. Are you ready to take on a pivotal role in the dynamic world of Telecommunications? Are you a seasoned IT professional with a knack for bridging the gap between business needs and...
-
Program Manager
il y a 5 jours
Wavre, Belgique Jefferson Wells Temps pleinLocation: **Wavre** - Type: **Contracting** **#18769** **Program Manager**: Brabant Wallon - contracting Our partner is looking for an **Program Manager **to join its team. This international company is well-known for its research, development and marketing of pharmaceutical and biotechnology products. The** Project Manager** applies the knowledge,...
-
Employe Qualite
il y a 3 jours
Wavre, Belgique EQUIP SA Temps plein_**1.**_ _**Qualité générale**_ - Contrôles et améliorations du système qualité; - S’assurer que la qualité et la traçabilité soit respectée à tout moment dans l’atelier de production ; - Vérification et suivi de la traçabilité (étiquetage, n° de lots, Fifo, ) ; - Relevé et vérification des T ; - Maintenir la gestion optimale des...
-
Deviation & Capa Specialist
il y a 4 jours
Wavre, Belgique Jefferson Wells Temps pleinLocation: **Wavre** Type: **Contracting** **#16992** **Deviation & CAPA Specialist**: Walloon Brabant - Contracting **#deviation #capa #QA #quality #qualitysystems #continuousimprovement #GMP #pharma** You have a previous experience in the **pharmaceutical industry**? You have a good knowledge of **GxP**? You are **solutions oriented**? Keep reading the...
-
General Manager
il y a 5 jours
Wavre, Belgique Golden State Supply LLC (730) Temps plein**General Manager [OTE] - Store 9926**: Apply Location: 5885 47th Ave, Sacramento, CA 95824 Time Type: Full time Posted On: Posted 12 Days Ago Job Requisition ID: R-0460288 **Primary Responsibilities** - Achieve overall store sales goals and service objectives - Manage and grow Professional Customer relationships/sales, including building and holding...
-
Approvisionneur/se
il y a 4 jours
Wavre, Belgique Actief Interim Temps pleinNous recherchons pour la société Automatic Systems, un.e approvisionneur.se : Vous êtes sous la responsabilité du Supply Chain Manager. Votre rôle consiste à superviser le processus de commande fournisseur dans le cadre de la production d'équipements, depuis son attribution au département de planification jusqu'à sa réception dans notre magasin....