Descripción de la oferta
KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain (Cerdanyola del Vallés- Barcelona), Italy (Monsano-Ancona), Germany (Frankfurt), Denmark (Copenhagen) and a Liaison office in South Korea (Seoul), offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.KYMOS GROUP has a young and dynamic staff of more than 330 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.AtKymos Group, we provide specialized analytical services to the pharmaceutical industry in regulatedGMP and GLPenvironments. Our laboratories are equipped with a wide range of analytical instruments and computerized systems, including solutions such asLIMS, Empower, laboratory software, and other corporate systems. We are currently looking for someone to join ourComputer System Validation — CSVarea, based inCerdanyola del Vallès, Barcelona. We are looking for a profile with some previous experience or knowledge in CSV, quality, laboratory environments, or computerized systems, who is willing to continue developing in a regulated and highly technical environment.Main objectiveTo support the validation, maintenance, and review activities of computerized systems used in the laboratory and in other company processes, ensuring compliance with applicable regulatory requirements inGxPenvironments.Main responsibilities- Participate incomputer system validationactivities, both for laboratory equipment and other systems.- Support the preparation and review of validation documentation, such asValidation Plan, Risk Analysis, Design Review, IOPQ, Traceability Matrix, andFinal Validation Report.- Collaborate in the assessment ofdata integrityrequirements, regulatory compliance, and change control.- Support the preparation and execution of tests, test plans, and user acceptance testing.- Participate in periodic reviews of computerized systems.- Collaborate withQuality Assurance, IT, LIMS, and Laboratoryteams on projects related to computerized systems.- Support internal audits and the preparation of documentation related to CSV.Requirements- University degree inEngineering, Chemistry, Physics, Pharmacy, or a related field.- Previous experience, internships, or knowledge incomputer system validation, quality, laboratory environments, IT, or regulated GxP environments.- Familiarity with the computer system validation lifecycle and related documentation.- Knowledge of regulations or guidelines such asGAMP 5, EU GMP Annex 11, 21 CFR Part 11, ISO, or GxP.- Knowledge or experience with systems such asLIMS, Empower, SCADA, ERP, or other laboratory or corporate software.- Ability to work collaboratively with technical departments, Laboratory, IT, and Quality Assurance teams.- Strong organizational skills, attention to detail, and a compliance-oriented mindset.- Advanced level ofSpanish and English, both spoken and written.If you join us, you will enjoy:- Joining a specialized and growing company.- Professional development in a technical area with high demand within the pharmaceutical industry.- Support and guidance from experienced Quality, Laboratory, IT, and Systems teams.- A collaborative and dynamic work environment.- Flexible working hours and an intensive schedule on Fridays.- Hybrid working model, with the majority of work carried out on-site.- Access to an employee benefits platform.- 23 vacation days per year, plus December 24th and December 31st as additional days off.- Offices located in Cerdanyola del Vallès, next to Collserola Natural Park, with a fully stocked canteen and rooftop space.If you join us, you will enjoy:- Working in a dynamic company with a highly qualified growing team- Professional development and collaborative environment and a culture of empowerment.- Flexible Working Hours and intensive schedule on Friday.- Hybrid work, but mainly in the office.- Access to the employee benefits flexibility platform.- 23 vacation days per year plus 24th and 31th of December.- Fully stocked canteen and rooftop space (coffee, fruits, snacks, and beverages).- Our headquarters located in Cerdanyola del Vallés, an amazing place at the foothill of Collserola Park, the green lung of Barcelona, with our Rooftop terrace.Kymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic#J-18808-Ljbffr
