Computer System Validation Specialist

hace 2 semanas

Barcelona, España Centrient Pharmaceuticals A tiempo completo

Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals.
We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.
We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.
With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs.
We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.
Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades.
Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico.
Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The Global Quality department has a vacancy in its Barcelona team for the following position: The Position Reporting to the IT Quality and Validation Manager, the CSV Specialist will maintain the validated state of global IT systems (e.g.
: SAP) according to applicable regulations (e.g.
: GxP, SarbOx,…).
Will comply with cGMP as meant by CFR part 11, EU GMPs Annex 11, and where appropriate GAMP as defined in Centrient policies and ISOPs.
Ensure embedding of Quality and Validation in the total Centrient IT approach, thinking and acting.
Coach and train direct colleagues as well as Key-Users.
Defines IT Quality system and validation methodology?, Organizes quality oversight of IT activities with QA, Monitors IT Risks and ensures Compliance?, Is the key contact for auditors.
The main activities and responsibilities: SAP implementation and validation experience is a must.
Maintains IT GxP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.
Executes Change Control governance in line with processes and stakeholders like QA, Finance, etc.
Acts as System Matter Expert on IT Quality and Validation.
Coordinate the Yearly Reviews on validated/qualified systems.
Manages validation projects.
Performs activities that contribute to the validated state of the systems that are in scope of validation such as change control, testing and organization of test sessions, investigations and preparation/execution of validation protocols and reports.
Timely escalating problems in the approval process and setting up.
Requirements The Ideal Candidate: Degree in Life Sciences, Computer Science or related fields.
Minimum of 3' experience with enterprise systems in a regulated environment Experience with Application Lifecycle Management Systems is desirable.
Fluent in English language (written and spoken).
Strong knowledge of GxP regulations, ideally in the field of computer system validation.
Good knowledge of cGxP and GDPR requirements.
Deep expertise in Computer System Validation for the Pharmaceutical industry.
Knowledge in the IT and telecommunications domain.
Strong Quality and continuous improvement mindset.
Strong communications skills.
Communicates effectively with a diverse audience.
Independent and reliable worker.
Intercultural skills.
Benefits Terms and reward We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals.
The organization is very flat.
You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.
The Procedure Please submit your application via the 'apply' button and upload your CV & cover letter in English.
We also ask you to include information on your current remuneration.
Only applications with CV and Cover Letter will be considered.
For more detailed information about the role and about the Recruitment & Selection process you can contact us via ****** We invite you to visit our website www.centrient.com for information about our company.
Reference check procedures are part of the Centrient Recruitment & Selection Process.
You will be contacted when a reference check is required.

  • Computer System Validation Specialist

    hace 2 meses

    Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completo

    Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our commitment...

  • Computer System Validation Expert

    hace 3 días

    Barcelona, España Aizon A tiempo completo

    **Who we are** Aizon is an AI software provider that transforms manufacturing operations using advanced analytics, artificial intelligence, and other smart factory technologies. **Our mission is to improve global health in order to change patients’ lives**. We aim to do that by optimizing the way medicines are manufactured so that pharma and biotech...

  • Computer System Validation Coordinator

    hace 3 días

    Barcelona, España Kymos A tiempo completo

    Kymos Group is made up of different laboratories with a wide variety of instruments and computerized systems, basically to provide analytical services for the pharmaceutical industry following cGMP and GLP regulations and to manage the internal processes. The company has the headquarters in Barcelona and subsidiaries in Ancona (Italy) and in Frankfurt...

  • Computer System Validation

    hace 4 meses

    Barcelona, España Kymos Group A tiempo completo

    Kymos Group is made up of different laboratories with a wide variety of instruments and computerized systems, basically to provide analytical services for the pharmaceutical industry following cGMP and GLP regulations and to manage the internal processes. The company has the headquarters in Barcelona and subsidiaries in Ancona (Italy) and in Frankfurt...

  • Computer System Validation and Laboratoy Instrument

    hace 2 días

    Barcelona, España Kymos A tiempo completo

    Kymos Group is made up of different laboratories with a wide variety of instruments and computerized systems, basically to provide analytical services for the pharmaceutical industry and to manage the internal processes. The company has the headquarters in Barcelona and subsidiaries in Ancona (Italy) and in Frankfurt (Germany). The most significant...

  • Quality Validation Engineer

    hace 2 meses

    Barcelona, España Ecolab A tiempo completo

    At Ecolab we are looking for a Quality Validation Engineer (Computer Systems Valdiation) to join our Computer Software Assurance & Validation Team.What You Will Do: Lead or assist in business risk/impact determinations to determine when validation is required.Develop internal/external connections with development, implementation and business teams to provide...

  • Computer System Validation Senior

    hace 12 horas

    Barcelona, España MA (Montreal Associates) A tiempo completo

    Position: Senior CVS Specialist (Computerized Validation Systems)We are seeking a Senior CVS Specialist to join our global team. This is an exceptional opportunity to tackle complex, international challenges in the pharmaceutical and chemical industries, working with cutting-edge technologies in a dynamic and high-performance environment.Key...

  • Computer System Validation Senior

    hace 3 horas

    Barcelona, España MA (Montreal Associates) A tiempo completo

    Position: Senior CVS Specialist (Computerized Validation Systems)We are seeking a Senior CVS Specialist to join our global team. This is an exceptional opportunity to tackle complex, international challenges in the pharmaceutical and chemical industries, working with cutting-edge technologies in a dynamic and high-performance environment.Key...

  • Quality Validation Engineer

    hace 3 meses

    Barcelona, España Ecolab A tiempo completo

    At Ecolab we are looking for a **Quality Validation Engineer** (Computer Systems Valdiation) to join our Computer Software Assurance & Validation Team. **What You Will Do**: - Lead or assist in business risk/impact determinations to determine when validation is required. - Develop internal/external connections with development, implementation and business...

  • IT Quality Computer System Assurance

    hace 7 meses

    Barcelona, España Ambit BST A tiempo completo

    We are seeking a highly motivated and competent** IT Quality Computer System Assurance **to join our team and work together with our client, a multinational pharmaceutical company. This role is crucial in ensuring the existence and compliance with common regulations and efficient and effective Quality Management processes/systems in the global IT Quality...

  • System Interoperability Specialist

    hace 1 mes

    Barcelona, Barcelona, España Esperanto A tiempo completo

    Job Overview: System Interoperability SpecialistWe are seeking a highly skilled System Interoperability Specialist to join our team. The successful candidate will have a strong background in software integration and system interoperability.About Esperanto:We are a company that values innovation and excellence in all aspects of our business. Our team is...

  • Senior Validation Manager

    hace 3 meses

    Barcelona, España Boehringer Ingelheim España, S.A. A tiempo completo

    As a (Senior) Validation Manager in our Global Quality team, you will play a pivotal role in the digital transformation of our quality control laboratories at Boehringer Ingelheim. Your expertise in validation standards and test strategy development, in compliance with our GxP regulations, will drive this change. **Functions and Responsibilities**: -...

  • Validation Specialist

    hace 3 semanas

    Barcelona, España Conwastepr A tiempo completo

    AVISO de ClasificadosOnline Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversion o Fraude.NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email.Evite el Fraude AppleOne Validation Specialist Para trabajar la mayor parte del tiempo en: Barceloneta Manufactura / Almacen -...

  • Validation Specialist

    hace 3 semanas

    Barcelona, España Conwastepr A tiempo completo

    AVISO de ClasificadosOnlineLos patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversion o Fraude.NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el FraudeAppleOneValidation SpecialistPara trabajar la mayor parte del tiempo en:BarcelonetaManufactura / Almacen -...

  • Senior Validation Manager

    hace 7 meses

    Sant Cugat del Vallès, Barcelona provincia, España Boehringer Ingelheim España, S.A. A tiempo completo

    **(Senior) Validation Manager - Global Quality**: As a (Senior) Validation Manager in our Global Quality team, you will play a pivotal role in the digital transformation of our quality control laboratories at Boehringer Ingelheim. Your expertise in validation standards and test strategy development, in compliance with our GxP regulations, will drive this...

  • Validation Specialist

    hace 3 semanas

    Barcelona, España Conwastepr A tiempo completo

    AVISO de ClasificadosOnline Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversion o Fraude.NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude AppleOneValidation Specialist Para trabajar la mayor parte del tiempo en:Barceloneta Manufactura / Almacen -...

  • Validation Specialist

    hace 3 semanas

    Barcelona, España Conwastepr A tiempo completo

    AVISO de ClasificadosOnlineLos patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversion o Fraude.NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el FraudeAppleOneValidation SpecialistPara trabajar la mayor parte del tiempo en:BarcelonetaManufactura / Almacen -...

  • Computerized System Validation Professional

    hace 2 semanas

    Barcelona, Barcelona, España Grifols, S.A A tiempo completo

    About the OpportunityGrifols, S.A. is a global healthcare company that offers a brilliant opportunity for talented professionals like you to develop their careers in an excellent working environment.We are looking for a Computerized System Validation Professional to perform functions related to process improvements and general procedures in the Quality...

  • Validation Specialist

    hace 3 semanas

    Barcelona, España Conwastepr A tiempo completo

    AVISO de ClasificadosOnline Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversion o Fraude.NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude AppleOneValidation Specialist Para trabajar la mayor parte del tiempo en:Barceloneta Manufactura / Almacen -...

  • IT Quality Computer System Assurance

    hace 7 meses

    Barcelona, España amaris A tiempo completo

    Job description Take your career to the next level with Amaris Consulting as an IT Quality Computer System Assurance in Barcelona. Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment. Join Amaris Consulting, where you can develop your potential and make a difference...