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, ensuring food safety, or helping find cures for cancer
Location/Division Specific Information
Bulgaria, Serbia, Pharmacovigilance
What will you do?
1. Assessing and defining assigned validation projects.
2. Writing, reviewing, and implementing project validation protocols for standard & customized systems.
3. Validation of PV System.
4. Raising discrepancies and closeout test documentation.
5. Liaising with Internal team/ vendors in case of any OQ failures and preparing a summary of such observations for team meetings with evidence.
6. Conducting OQ/PQ deviation investigations, such as validation failures, complaints, and hold investigations. Identifying & implementing appropriate corrective actions.
7. Resolving technical issues.
8. Collaborating with IT and QA Departments.
9. Communicating with internal and external clients.
Education
Bachelor's degree or equivalent combinations of education, training, and relevant work experience.
Experience
Minimum of 2 years' experience in Patient Safety Computer Systems implementation, preferably within the biotech or pharmaceutical sector. Experience with Argus, Gateways, and other PV systems AI platform. Self-motivated and proactive with confirmed time-management skills.
Knowledge, Skills, Abilities
* 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 Word and Excel.
Our 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.
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