Computer System Validation Coordinator - Barcelona, España - Kymos

Kymos
Kymos
Empresa verificada
Barcelona, España

hace 1 mes

Isabel García

Publicado por:

Isabel García

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Descripción

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 (Germany).


The most significant instrumental systems are related to liquid and gas chromatography from Waters and Agilent brands, managed by the Empower software, mass spectrometry from Sciex, Agilent, and Thermo brands managed by Analyst, MassHunter and Chromeleon softwares and a myriad of other minor instrumental systems used in the physicochemical, biological and microbiological determinations carried out in the company.

The laboratory has implemented a LIMS system (LabWare) that manage the main analytical flows of the company also including the subsidiaries.


Your responsibilities will be:


  • Ensure compliance with tasks linked to the computer system validation, establishing the level of compliance in data integrity and other regulatory requirements prior to system acquisition, participating in the deployment process and in postinstallation qualification and validation.
  • Draft the necessary documentation for computerised systems validation in accordance with the instrument life cycle and system complexity following the current cGMP and GLP regulations and GAMP 5 recommendations.
  • Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans.
  • Manage changes in computerized systems in collaboration to Quality Assurance, evaluating the change impact and establishing the computer system validation requirements in the change control records.
  • Carry out periodic reviews of the computerized system and maintain and verify the different support software for the management of the instruments.
  • Assist Quality Assurance during client audits and regulatory inspections in computer system validation issues.

Education:


  • You should have a degree in Engineering (Chemical, Electronic, Mechanical, Electrical, Industrial, etc.), Chemistry or Physics, or similar, with proven experience in computer system validation.

Required skills for the position:


  • Selfmotivated with good organisational / time management skills and ability to work with mínimal supervision.
  • A methodical approach to problem solving.
  • Teamwork skills for an effective work in collaboration with Laboratory staff and IT, LIMS and Quality Assurance Departments.
  • Ability to work under pressure to tight deadlines.
  • Ability to identify and address a query from laboratory users.
  • Continuous development of system / software knowledge.
  • Spanish language and very good level of English, both spoken and written.
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