Salary Range:
52200.00 - 96900.00
Band
Level 3
Job Description Summary
#LiHybrid
Location: Puurs
The Validation Expert performs and manages the qualification status of validated process equipment and processes as well as modification activities to comply with cGMP requirements on time and in the intended quality so that site validation program conforms to overall regulatory expectations.
Job Description
Major accountabilities:
Promote quality excellence: Take charge of preparing and verifying process requalification protocols and reports with meticulousness and attention to detail ensuring that every step is accurately documented.
Manage requalification activities: Plan and execute periodic requalification initiatives for manufacturing equipment and processes including sterilisation cleaning and aseptic process simulations (medium fills). You will be the go-to person for ensuring smooth operations.
Ensure regulatory compliance: Ensure that all requalification activities adhere to current regulatory requirements proactively managing any deviations and providing recommendations to prevent recurrence. Your expertise will be crucial in maintaining our sites compliance.
Maintain audit readiness: Maintain a state of audit/inspection readiness for all activities and projects taking ownership of upholding our high standards of quality under your guidance.
Share your expertise: Offer valuable technical expertise in conducting risk assessments and collaborate with cross-functional teams to effectively analyse and mitigate process risks. Your insights will not only ensure compliance but also optimise our operations for enhanced efficiency.
Essential requirements:
Scientific/Engineering Degree.
Previous experience within Quality/MS&T/Production department of a GMP manufacturing site.
Proactivity and flexibility.
Fluent in English and Dutch.
At Novartis were committed to reimagining medicine together- and rewarding the people who make it happen.
Expected Annual Base Salary Range: 52.200 - 96.900 EUR.
The base salary offered is determined based on gender-neutral objectives such as relevant skills competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed
periodically.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally such as insurance plansretirement
plans wellbeing resources and global recognition addition we provide flexible and hybrid working options where possible and minimum 14 weeks paid parental leave.
Commitment to Diversity and Inclusion/EEO:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Assembly Language (ASM) Change Controls Chemical Engineering Chemistry Continual Improvement Process Cost Reduction Data Analytics Electronic Components General Hse Knowledge (Inactive) Including Gdp (Inactive) Knowledge Of Capa (Inactive) Knowledge Of Gmp (Inactive) Lean Manufacturing Manufacturing Processes Manufacturing Production Pharmaceutics Process and Cleaning Validation (Inactive) Process Control Process Engineering Risk Management Root Cause Analysis (RCA) Six Sigma Standard Operating Procedure (SOP) Workforce Planning
Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 52200 - 96900
Validation Expert • Puurs, Belgium
Om onze groeiambities waar te maken zijn wij voortdurend op zoek naar nieuw talent en streven we ook naar een werkomgeving waar onze medewerkers gelukkig en vooral volledig zichzelf kunnen zijn.Onz... Laat meer zien
Allereerst uit onze verschillende vacatures.Maar je hebt bij SGS nog een andere keuze.Kies je voor verdiepen of kies je voor verruimen?.The information below covers the role requirements, expected ... Laat meer zien
What is a Functional Analyst at Cream? Embrace your role and work on various projects: Internet and mobile application, Digital/e-Commerce, Artificial Intelligence, real-time, Your tasks Translatin... Laat meer zien
Fortil is an international engineering and technology consulting group, built on an independent model and bringing together over 2,500 employees across 14 countries.Fortil fosters an entrepreneuria... Laat meer zien
Bij Evolane is het onze missie om bedrijfsapplicaties te optimaliseren, organisaties te ontzorgen en eindgebruikers de beste user experience te bieden.Een aanpak op maat zorgt ervoor dat elk van on... Laat meer zien
Wie ben 👉 jij? Wat wil 👉 jij? Dat telt voor ons! De nadruk ligt op onze medewerkers, op onze 'fam'ployees.Maar voor je verder leest, misschien toch even dit: Privatum is gevestigd in Hasselt en ... Laat meer zien
Make sure to apply with all the requested information, as laid out in the job overview below.Europese marktleider in het ontwerpen, assembleren en verkopen van snijmachines voor de voedselverwerken... Laat meer zien
Reports to the Supervisor QA Validation (A.As a Senior Quality Engineer, you safeguard quality levels by monitoring and ensuring that all operations at all levels are carried out in accordance with... Laat meer zien
Why we approach Applied Observability from within an integration point of view? Simple.Integration is where context lives.Integration stitches APIs, events, data contracts and workflows into one li... Laat meer zien
We are looking for an IVVQ Engineer to lead system integration, verification, validation, and qualification activities across innovative, high-impact projects.In this role, you will oversee the ful... Laat meer zien
Vanbreda Risk & Benefits is de grootste Belgische.Om onze groeiambities waar te maken zijn wij voortdurend op zoek naar nieuw talent en streven we ook naar een werkomgeving waar onze medewerkers ge... Laat meer zien
UCB recherche un/une Ingénieur·e Fiabilité orienté·e amélioration continue pour améliorer la fiabilité et la disponibilité des actifs sur le site de Braine-l’Alleud, en respect des exigences GMP et... Laat meer zien
Sales Effectiveness Analyst (Excellence) | 40 hrs/week.The following information aims to provide potential candidates with a better understanding of the requirements for this role.We are looking fo... Laat meer zien
To view the Associate Consultant job description for our Montreal office, click here.Bain & Company is a global consultancy that helps the world’s most ambitious change makers define the future... Laat meer zien
At KPMG Belgium, professionals join a team of diverse and dedicated problem solvers, connected by a common purpose: turning insights into opportunities for clients and communities around the world.... Laat meer zien
Hands-on Mid-Senior Project Manager with great affinity for data measurement projects, from data measurement projects, from data flow setup to transformation to PowerBI dashboard.The implementation... Laat meer zien
Werkomgeving Ben je op zoek naar een uitdagende IT-functie als Technisch Analist waarbij je zowel je technische competenties als je praktische ingesteldheid kan gebruiken? Wens je te werken binnen ... Laat meer zien
SD Worx is een toonaangevende Europese leverancier van Payroll & HR-diensten met een wereldwijd bereik.We hebben kantoren in Europa en een kantoor op Mauritius.Ons doel? We brengen people solutions... Laat meer zien
