Computer System Validation Specialist
hace 1 semana
About Kymos Group
Kymos Group is a leading provider of analytical services for the pharmaceutical industry, adhering to cGMP and GLP regulations. Our company has a strong presence in Europe, with headquarters in Barcelona and subsidiaries in Ancona (Italy) and Frankfurt (Germany).
Our Instrumental Systems
We utilize a range of instrumental systems, including liquid and gas chromatography from Waters and Agilent brands, managed by Empower software, mass spectrometry from Sciex, Agilent, and Thermo brands managed by Analyst, MassHunter, and Chromeleon softwares. Our laboratory has implemented a LIMS system (LabWare) that manages the main analytical flows of the company, including our subsidiaries.
Your Role
We are seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with tasks linked to 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 post-installation qualification and validation.
Key Responsibilities
- 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 with Quality Assurance and IT department, 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.
Requirements
- 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.
- Self-motivated with good organisational/time management skills and ability to work with minimal supervision.
- A methodical approach to problem solving.
- Teamwork skills for effective collaboration with Laboratory staff and IT, LIMS, and Quality Assurance Departments.
- Effective fault finding in areas of chemical applications, mechanical, and electronic products.
- Ability to work under pressure to tight deadlines.
- Ability to identify and address queries 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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