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Programing Analyst who specialized in Computer System Validations, Pharmacovigilance

extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Bulgaria

Offer summary

Qualifications:

Bachelor's degree or equivalent experience, Minimum 2 years in Patient Safety Computer Systems, Experience with Argus and other PV systems, Solid understanding of regulatory standards, Proficient in Microsoft Office.

Key responsabilities:

Assess and define validation projects.
Write and review project validation protocols.
Conduct OQ/PQ deviation investigations.
Liaise with teams and vendors for issues.
Resolve technical issues and collaborate.

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Work Schedule

Other

Environmental Conditions

Office

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

What will you do?

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.

Education

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

Experience

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.

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 Microsoft 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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.