Computer System Validation and Laboratoy Instrument
hace 2 semanas
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 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 post-installation qualification and validation.
- Draft the necessary documentation for computerised systems validation in accordance with the instrument life cycle and system complexity following the current regulations and GAMP 5 recommendations.
- Manage changes in computerized systems and instrumentation 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.
- Manage the Instrument Corrective and Preventive Maintenance Plan of the company (and subsidiaries) supervising the maintenance activities entrusted to service suppliers and the internal and external qualifications/calibrations according to the established procedures.
- Negotiation with providers the different contracts and types of services.
- Follow-up incidents and unplanned maintenance actions, coordinating with both laboratory staff and service suppliers when necessary.
- Report and evaluate instrument maintenance KPIs, propose effectivity and cost improvements in the maintenance and qualification plans.
- Be involved in the acquisition of knowledge for new instrumental systems and be aware of upgrades to the systems in place.
- 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 and in the in the management of laboratory instrumentation.
***
**Required skills for the position**:
- Self-motivated 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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