- Manage staff and workload of the validation team. Provide coaching, training and mentoring for routine and complex activities.
- Asses and define the roadmap.
- Development and implementation of strategy and policies related to validation. Development and oversight of the execution of validation related documents throughout the system, including development of a comprehensive validation master plan covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification, computerized system
validation, ... - Support change control, investigations, and MBR's and SOP's updates. Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of tools.
- Represent the validation group and defend policies, program, and validation documentation during audits, regulatory inspections. Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure. Provide validation expertise for issue resolutions to support deviations or CAPA's and audit findings.
- Develop and co-approve cGMP documents including, but not limited to, Master Validation Plans, SOPs, protocols and forms to improve validation efficiencies.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Requires collaboration with cross functional team members, must be able to balance normal stress to meet deadlines for various validation projects - Minimum requirements
- You have a master's Degree in Science (e.g. Chemistry, Pharmacy, Agriculture) or equivalent.
- You have 3 to 5 years of experience in a pharmaceutical (sterile) manufacturing site.
- Experience in a cGMP environment is an asset. Experience in (medical device) quality & regulatory affairs is an asset.
- Ability to establish a validation strategy to manage multiple projects effectively and efficiently.
- Possess expert knowledge in equipment validation and calibration and broad knowledge related to quality assurance.
- You have good people management skills.
- Excellent written and verbal communication skills including presentation skills in English and French
-
Ms&t Process Validation Manager
1 week geleden
Catalent Neder-Over-Heembeek, BelgiëFor our sterile production site located in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are looking for a **MS&T Process Validation Manager.** · The manager reports directly to the MS&T & Product Development Director, and they're responsible fo ...
-
Manager, Aq, Validation
1 week geleden
Thermo Fisher Scientific Seneffe, België**Mission of function** · Production of biopharmaceutical production conform to the requirement of international quality defined by the FDA, the EMEA, the ICH, etc. · **Context of position and function** · This type of facility needs to be conformed to the rules and regulation of ...
-
QA Validation Manager
4 dagen geleden
Catalent Gosselies, BelgiëBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP m ...
-
Consultant Validation Manager
1 week geleden
Cognizant Brussels, BelgiëAbout Us · Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and e ...
-
Computerized System Validation Manager
4 dagen geleden
GSK Rixensart, België**Site Name**: Belgium-Rixensart · **Posted Date**: Jun · The "Computerized System Validation" Lead will be responsible for managing a team of approximately 20 people (outsourced workers) who delivers fit-for-purpose Computerized System Validation activities. · The incumbent wil ...
-
Test Manager
6 dagen geleden
AXA Brussels, BelgiëAXA is niet alleen leider op de verzekeringsmarkt, het is ook een innoverende onderneming die de mens centraal plaatst in haar prioriteiten. · Met meer dan 400 medewerkers bekleedt het IT-departement een centrale plaats in de activiteit van AXA. Het leidt de meest innoverende pro ...
-
Stagiair Actuaris
1 week geleden
AG Insurance Brussels, België**Daarom kies je voor AG**: · Een werkplek waar je zelf **het heft in handen** mag nemen. Waar iedereen je aanmoedigt om te tonen wat jij in je mars hebt. En waar je collega's samen met jou hun schouders zetten onder de **toekomst**. Jij bent een **durver** die de klant écht cent ...
-
Administratief Bediende
1 week geleden
IN·ZO Brussels, BelgiëFUNCTIE: · Operational Project Asstistant. · OBJECTIEF: · PL's (Projectleiders) en POM's (Programmamanagers) proactief ondersteunen bij: · - Coördinatie en opvolging gedurende de gehele looptijd van een infrastructuurproject (van begin tot eind); · - Opvolging van het project op ...
-
Project Manager
1 week geleden
Connect-ICT Brussels, België**Project Manager SCM** · - Sibelga prévoit la construction d'un nouvel entrepôt qui nécessite une révision approfondie de l'organisation des différents entrepôts, des stocks et des flux de marchandises sous-jacents (au sein des entrepôts & sur le site de Sibelga). · - La mission ...
-
Marketing & Reporting Officer (H/F)/x)
1 week geleden
Alphacredit Brussels, België**MARKETING & REPORTING OFFICER** · **Contexte** · - BNP Paribas Group et Jaguar Land Rover (JLR) collaborent ensemble depuis janvier 2023 pour pro-poser une offre de produits financiers aux clients JLR. · - Pour le Benelux, cette collaboration se traduit par une Virtual Joint Ve ...
-
Account Officer
1 week geleden
NBB Brussels, België-Postuler jusqu'au: · 22 janvier 2023 · **Environnement**: · La Banque nationale de Belgique (BNB) recherche un(e) comptable pour la validation des micro-données dans le secteur des investissements directs avec l'étranger. · Le département Gestion des micro-données centralise la ...
-
Responsable Opérationnel Du Laboratoire
7 uur geleden
Cliniques Universitaires Saint-Luc Brussels, BelgiëCette fonction comprend 2 rôles distincts: Responsable Opérationnel du Laboratoire d'hématologie spéciale et de la banque de sang et gestionnaire de projets · **Le Responsable Opérationnel** (ROP) a pour mission d'assurer le management opérationnel du Laboratoire d'hématologie sp ...
-
Quality and Audit Manager
1 week geleden
Colas Brussels, België**Vos principales responsabilités**: · RESPONSABILITÉS · - Gestion du système de management intégré (SGI) · - Gérer la qualité des différents processus (opérationnels et documentaires) en assistant les responsables impliqués dans la formalisation, le respect de la conformité et l ...
-
Analyste SAP Fica
1 week geleden
RESA Brussels, BelgiëDans le contexte de profonde évolution que connaît le monde de l'énergie, les défis à relever sont nombreux et majeurs. RESA a entamé un processus de transformation de l'entreprise et reste plus que jamais déterminée à remplir les missions qui lui sont confiées avec efficacité et ...
-
Head of Validation
7 uur geleden
Elemed Brussels, België**About the job** · Title: Head of Validation · Location: Liège, Belgium · The company · This company has been enhancing performance in healthcare across the world for over 150 years so have a huge amount of history behind it including being the first company to mass-produce dres ...
-
Information Security Officer
1 week geleden
Experis Belgium Brussels, BelgiëLocation: · **Bruxelles** · - Type: · **Contracting** · **#19971** · **Information Security Officer (H/F)** · **Département Informatique** · **MISSION**: · **FONCTION**: · - Vous développez et maintenez le « Information Security Management System » (ISMS). Vous êtes responsable p ...
-
Project Officer
1 week geleden
Elia Brussels, België**Expertise**: · Ingénieurs · **Numéro de référence**: · 6849 · Description de fonction · Le Program Management Officer (PMO) supervise, coordonne et optimise les programmes de manière indépendante, en étroite collaboration avec le Program Manager (PM). · Ce PMO sera responsable ...
-
Responsable Adjointe Boutique
1 week geleden
KGR Brussels, BelgiëNous recrutons un(e) responsable adjoint pour une enseigne de prêt à porter · Vous possédez une forte sensibilité pour l'univers de la mode et voulez transmettre votre connaissance des produits · Rattaché.e directement au RESPONSABLE DE MAGASIN, l'Adjoint Responsable Magasin F/H ...
-
QA Production Technician
5 dagen geleden
Mithra Pharmaceuticals SA Brussels, BelgiëOverview: · Mithra est à la recherche d'un QA Production Technician pour sa plate-forme intégrée Production/R&D basée à Flémalle. · **Responsibilities**: · - Rédaction, revue et/ou approbation des documents qualité opérationnels (procédures, instructions de travail, master batch ...
-
Product & Pricing Data Analyst
1 week geleden
Oliver James Associates Brussels, België**Notre client est un acteur européen majeur de la distribution de pièces détachées.** · **Finalités**: · 1. Est responsable de la gestion des articles dans l'ERP et des mises à jour des bases de données liées aux articles. · 2. Est garant des changements de tarifs et prix d'acha ...
Consultant Validation Manager - Brussels, België - Cognizant Technology Solutions
Beschrijving
About Us
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S.,
Cognizant, a member of the NASDAQ-100, is ranked 195 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at
About Cognizant's
Intelligent Lifescience , OT & IT-enabled products will soon result in the proliferation of data and disrupt virtually all industries. To be successful, both large and small companies must leverage OT & IT capabilities by designing modern products that fundamentally connect people with processes. Within Cognizant, we engineer industry-aligned, IoT/OT -enabled products that merge industry needs with human drivers.
Our intelligent products will revolutionize experiences and result in exciting, transformative outcomes. Without human-centered thinking, connected products are just standalone things—but with it, our modern connected products facilitate a unified way of life enjoyed by all.
Job Description
We are currently looking for a talented person to take on the role of Validation Manager to asses, design and lead
The Validation Manager is responsible for setting strategy and policies, and oversight of the Validation Department and programs and related activities including: Qualification and re-qualification of facilities, utilities, equipment, computerized systems, cleaning, disinfection, process validation, requalification ...
A strong focus is on sterility assurance (validation of steam/dry heat/gamma/EO sterilization, media fill, smoke testing,...).The scope includes all regulated areas of manufacturing.
In this role, your responsibilities will be as follows
Desired profile
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Cognizant. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Your office will be based in Brussels.