Programming Analyst - Computer System Validations, Pharmacovigilance

October 30

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

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. • 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.

Requirements

• 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.