Qualification and Validation CSV Specialist

  • Company:
    Catalent Pharma Solutions
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    23 hours ago
  • Category:
    General

Description de l’emploi

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For our growing production site located in Brussels (Neder-Over-Heembeek) specializing in sterile technologies, we are currently looking for a Qualification & Validation Computerized System Validation (CSV) Specialist

The Qualification & Validation Specialist reports to the Qualification & Validation non-aseptic leader and will be responsible for Computerized System Validation activities (including production and QC lab) and is involved in routine Qualification & Calibration activities. The ideal candidate is a driven professional who has expertise in the field of Computer System Validation. What we offer is an exciting role in a dynamic team, as well as a chance to further develop your skillset and grow within an international company.

The Role

+ Perform initial & periodical Computerized System validation for all GMP equipment at the site (production & QC lab) 21 CFR Part 11

+ Review and approve risk assessment link to CSV

+ Performed routine Calibration & qualification activities

+ Ensure that all activities are performed according to the schedule

+ Ensure that all activities are properly documented

+ Write qualification and validation protocols and reports and other documentation related to the activities

+ Investigate deviations and execute CAPAs

+ Define and execute improvement projects and initiatives

+ Participate in customer and authority audits

+ Can be involved in other process validation activities

The Candidate

+ Master degree in Biology/(Bio-)Engineering/Automation or equivalent

+ Relevant qualification & validation experience in the pharmaceutical/agro-food industry

+ Experience in Computer System Validation

+ Fluent in French and English

+ Integrity, positive energy and mindset, team-player

+ Excellent communication skills

+ Accountability for results and persistence

+ Stress resistant

+ Risk analysis thinking

Position Benefits :

+ What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile business

+ Potential for personal development within an international company

+ Defined career path and annual performance review and feedback process

+ Contributory pension and benefits package all offered from day one of employment

+ 36 days’ holiday + bank holidays

Catalent offre des opportunités enrichissantes pour faire avancer votre carrière! Rejoignez le leader mondial du développement et de la distribution de médicaments et aidez-nous à proposer plus de 7 000 produits vitaux aux patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec les sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser les nouveaux médicaments, du développement précoce aux essais cliniques et au marché. Catalent produit plus de 70 milliards de doses par an et chacune d’entre elles sera utilisée par quelqu’un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent. Plus de produits. De meilleurs traitements. Fournis de manière fiable. ™

Visitez www.catalent.com/careers pour explorer les opportunités de carrière.

Catalent est un employeur favorisant l’égalité des chances et l’action pour l’équité. Tous les candidats qualifiés seront considérés pour un emploi sans distinction de race, de couleur, de religion, de sexe, d’origine nationale, d’incapacité, de statut de vétéran protégé, d’orientation sexuelle ou d’identité de genre. Si vous avez besoin d’une aide raisonnable pour une partie du processus de candidature ou d’embauche en raison d’un handicap, vous pouvez soumettre votre demande en envoyant un courrier électronique confirmant votre demande d’adaptation et en indiquant le numéro du poste, le titre et l’emplacement à l’adresse DisabilityAccommodations @ catalent. com. Cette option est réservée aux personnes nécessitant une adaptation en raison d’un handicap. Les informations reçues seront traitées par un employé américain de Catalent, puis acheminées vers un recruteur local qui fournira une assistance pour assurer la prise en compte appropriée du processus de candidature ou d’embauche.

Avis aux représentants des agences et des entreprises de recherche: Catalent Pharma Solutions (Catalent) n’accepte pas les CV non sollicités d’agences et / ou de sociétés de recherche pour cette offre d’emploi. Les curriculum vitae soumis à un employé de Catalent par une agence tierce et / ou une entreprise de recherche sans accord de recherche écrit valide et signé, deviendront la propriété exclusive de Catalent. Aucun frais ne sera payé si un candidat est embauché pour ce poste à la suite d’une recommandation non sollicitée d’une agence ou d’une entreprise de recherche. Merci.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.





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