Validation Engineer CSV
Functieomschrijving:
* Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems
* Responsible for the validation documentation through approval and implementation
* Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP, cGLP's and Sanofi Procedures
* Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times
* Ensures projects are managed in conjunction with all required Sanofi and cGMP regulatory standards
* Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements
* Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate
* Investigates/troubleshoots validation issues
Profiel:
We are looking for a
validation engineer who has project experience with validation of software packages and computerized systems has:
* Strong communication skills
* The capability of working independently and learns fast
* The ability to execute project to plan
* A good knowledge of Computer Systems Validation
* A full understanding of relevant quality and compliance regulations
* The capacities of troubleshooting validation issues
* Minimum a few years experience working in a pharmaceutical sector and GMP environment
* A very good knowledge of English and Dutch
Knowledge or experience with DCS systems (Emerson DeltaV) is strong advantage
Offer as a consultant:
* A permanent contract with a competitive salary, complemented by a monthly fixed expense allowance, a company car and fuel card or a monthly gross bonus. Additional benefits include €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus.
* This package is further enhanced with access to Benefits at Work, sport & culture vouchers, and eco vouchers.
* You'll also benefit from a varied and dynamic training offering, including both job-specific and cross-functional courses
* Expect regular feedback and check-ins with your dedicated HR Business Partner
* Get to know your fellow consultants during our networking events and team-building activities
* Kickstart your career at USG Professionals with our two-day Bootcamp
Offer as a freelancer:
* Streamline your freelance career with the USG EASY app
* Receive personalized project proposals based on your profile and availability
* Enjoy transparent follow-up of your invoicing process
* Manage all your administration in one app
Company info:
USG Professionals connects the expertise and ambitions of highly educated professionals with the challenges of clients across six different fields: Engineering & Science, ICT, HR, Legal and Finance. We support our clients with temporary needs through project sourcing and with the permanent filling of open positions through recruitment & selection.