Computerized System Validation Technical Expert (M/F)

Computerized System Validation Technical Expert (M/F)
Empresa:

Hovione


Computerized System Validation Technical Expert (M/F)

Detalhes da Vaga

Hovione Hovione is a 61 years Portuguese multinational company. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated contract development and manufacturing organization (CDMO) offering from drug substance to drug product intermediate to drug product. Hovione recognizes that people are the main asset for the company-s continued success, reaching over 1700 team members, from 20 different nationalities located in Portugal, US, Macao, Ireland, Hong Kong, Japan, India and Switzerland, including several production sites. In 2019, we were recognized as the third most attractive company to work for in Portugal. Working at Hovione means reaching for innovation and excellence in everything we do: for ourclients, our partners and, above all, our patients. To reinforce our team we are looking to fill the following position at our Loures site: As a Computerized SystemValidation Specialist you will participate in Computerized System projects developed in-house or off-the-shelf IT projects, assure that Computerized Systems Development documents meet regulatory and Hovione compliance requirements as well as throughout its life cycle and you will applya risk based approach throughout the life cycle of the Computerized Systemstaking into account patient safety, data integrity and product quality. Main responsibilities: To keep up-to-date on the latest regulations regarding Computerized Systems life cycle; To promote data integrity principles, compliant with the applicable regulations and approved procedures; To assure that Computerized Systems are qualified/validated according to their intended use, product and regulatory requirements; To participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites; To participate on the alignment of Qualification and Validation methodologies among Information Technology, Quality Control, Automation and other areas to benefit computerized systems compliance; To participate on planning and/or establishment of Qualification and Validation requirements for each computerized system; To assure the required qualification activities ofnew or changed computerized system within the change control process. Profile: Degree in Computer Science, Software Engineering, Information Systemsor equivalent area; More than 3 years experience in ComputerizedSystems Validation work for full Computerized System Specialist; Training in Computerized Systems Validation, Data Integrity Principles and GAMP 5 Guide: Compliant GxP Computerized Systems; Good knowledge on Quality, cGMPs, ICH and ISO guidelines as well as experience on their application; RiskAssessment applied to Computerized Systems Life Cycle;; Experience in software testing; Experience in Quality Systems and practical background of validation principles; cGMP knowledge; Good communication skills; Verbal and technical writing skills English fluency (written and oral); We offer: Full time opportunity; Remuneration and social benefits adjusted to the job function and matching the experience; Excellent work environment, with a strong focus on quality. Hovione is an Equal Opportunity Employer. Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.


Fonte: Sercanto_Ppc


Área:

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