Work Schedule
Other

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!

Location/Division Specific Information

Bulgaria, Serbia, Pharmacovigilance

• Assessing and defining assigned validation projects.
• Writing, reviewing, and implementing project validation protocols for standard & customized systems.
• Validation of PV System.
• Raising discrepancies and closeout test documentation.
• Liaising 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
• Conducting OQ/PQ deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.
• Resolving technical issues.
• Collaborating with IT and QA Departments.
• Communicating with internal and external clients.

• Bachelor`s degree
• Equivalent combinations of education, training, and relevant work experience may be considered

• Self-motivated and proactive with confirmed time-management skills
• Experience with Argus, Gateways and other PV systems AI platform.
• Minimum of 2 years' experience in Patient Safety Computer Systems implementation preferably within the biotech or pharmaceutical sector.

• Solid understanding of regulatory standards and SOPs.
• Computer Systems Validation including execution of OQ and PQ
• Attention to detail and ability to identify and remediate issues found during testing.
• Highly effective verbal and written skills, including technical authorship.
• Proficient in Microsoft Office, particularly Microsoft Word and Excel