Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!\n\nLocation/Division Specific Information\n\nBulgaria, Serbia, Pharmacovigilance\n\nWhat will you do?\n\nAssessing and defining assigned validation projects.\nWriting, reviewing, and implementing project validation protocols for standard & customized systems.\nValidation of PV System.\nRaising discrepancies and closeout test documentation.\nLiaising with Internal team/ vendors in case of any OQ failures and prepare a summary of such observations and present then during team meetings with evidence\nConducting OQ/PQ deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.\nResolving technical issues.\nCollaborating with IT and QA Departments.\nCommunicating with internal and external clients.\nEducation\n\nBachelor`s degree\nEquivalent combinations of education, training, and relevant work experience may be considered\nExperience\n\nSelf-motivated and proactive with confirmed time-management skills\nExperience with Argus, Gateways and other PV systems AI platform.\nMinimum of 2 years’ experience in Patient Safety Computer Systems implementation preferably within the biotech or pharmaceutical sector.\nKnowledge, Skills, Abilities\n\nSolid understanding of regulatory standards and SOPs.\nComputer Systems Validation including execution of OQ and PQ\nAttention to detail and ability to identify and remediate issues found during testing.\nHighly effective verbal and written skills, including technical authorship.\nProficient in Microsoft Office, particularly Microsoft Word and Excel\nOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.