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Qualification and Validation CSV Specialist (h/f)

Ref 1254804

Geactualiseerd op 25 augustus 2020 via CATALENT

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Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products.  With over 85 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For our growing production site located in Brussels (Neder-Over-Heembeek) specializing in sterile technologies, we are currently looking for a Qualification & Validation Computerized System Validation (CSV) Specialist

The Qualification & Validation Specialist reports to the Qualification & Validation non-aseptic leader and will be responsible for Computerized System Validation activities (including production and QC lab) and is involved in routine Qualification & Calibration activities. The ideal candidate is a driven professional who has expertise in the field of Computer System Validation. What we offer is an exciting role in a dynamic team, as well as a chance to further develop your skillset and grow within an international company.


Perform initial & periodical Computerized System validation for all GMP equipment at the site (production & QC lab) 21 CFR Part 11 Review and approve risk assessment link to CSV Performed routine Calibration & qualification activities Ensure that all activities are performed according to the schedule Ensure that all activities are properly documented Write qualification and validation protocols and reports and other documentation related to the activities Investigate deviations and execute CAPAs Define and execute improvement projects and initiatives Participate in customer and authority audits Can be involved in other process validation activities
  • Transport et logistique / Soutien à la production

Hoe solliciteren?

Naam van de werkgever
CATALENT
Contactpersoon
Mr Belgium Stepstone
Presentatiewijze

postuler via le site Web

Website
http://www.stepstone.be/offres-d-emploi----1814279-inline.html?cid=Partner_ActirisExport
Opgelet! Het is niet nodig om Actiris te contacteren voor deze werkaanbieding. De vacature werd opgesteld door de werkgever. Actiris is niet verantwoordelijk voor de inhoud ervan en eventuele inbreuken tegen de wetgeving. Toch een opmerking over deze werkaanbieding? Aarzel dan niet om Actiris in te lichten.