QA engineer
- Puratos
- Aalst
- Permanent
-
Benefits- Group insurance
- Meal vouchers
- Smartphone
- Laptop
- Family hospital insurance
- Disability insurance
- Dental insurance
- Additional paid leave
- Remote work
- You are key member of the HACCP team, food defense team and local crisis management team (in case...
- You take part in the HACCP risk assessment, the annual HACCP verification, the annual management...
Expert in research data management
- University of Antwerp
- Wilrijk
- Fixed-term
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Benefits
- Group insurance
- Meal vouchers
- Internet cost / Subscription
- Parking
- Public transport contribution
- Eco Cheque
- Training
- Additional paid leave
- Remote work
- As a data manager, you will be responsible for organizing, managing, and archiving biological...
- You will support a dynamic team of both established and early-career researchers with a strong...
Validation Engineer
- TEC
- Antwerp
- Permanent
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities....
- Performs validation of systems in scope for which there is industry precedence but standards...
Clinical Trial Manager
- Express Medical
- Antwerp
- Fixed-term
- Ensure the clinical trial is conducted according to protocol requirements, study plans, internal...
- Communicate transparently and effectively, collaborating with both internal and external partners...
R&D Project Manager Building Materials
- Profile Group
- Multiple regions
- Permanent
-
Benefits
- Group insurance
- Company car
- Petrol card / Fuel card for electric charging
- Meal vouchers
- Laptop
- Internet cost / Subscription
- Individual hospital insurance
- Family hospital insurance
- Bicycle leasing
- Parking
- Public transport contribution
- Saint Nicolas
- Remote work
- Onze Project Managers hebben diverse achtergronden: master in de ingenieurswetenschappen of...
- Onze projectmanagers, die we intern sectorale deskundigen of certificatie-experts noemen, waarderen...
Junior Scientific Coordination Officer
- The International Dairy Federation
- Brussels
- Permanent
- You are part of a cross-functional and international team where you play a crucial role in...
- You facilitate the development of standards for methods of analysis and sampling for milk and milk...
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Validation Engineer
Job description
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- Performs validation of systems in scope 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 process systems in scope is in compliance with cGMP at all times.
- Ensures projects are supported 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.
- Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for systems in scope using Kneat paperless validation tool.
- Responsible for the validation documentation through approval and implementation.
- Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
Profile
- Bachelor or Master Industrial engineering or a relevant experience
- Knowledge of CGMP requirements in a regulated environment.
- Understanding of relevant quality and compliance regulations.
- Capable of troubleshooting validation issues.
- Experience: 2-4 years experience working in a pharmaceutical sector and GMP environment
- Experience with the validation of Clean Steam Generator system and Parts washers is an advantage
- Good knowledge of English and Dutch
Offer
- Company car
Naast een contract van onbepaalde duur met een aantrekkelijk salaris op maat, bieden wij je:
- maaltijdcheques van 8 euro per gewerkte dag;
- forfaitaire onkostenvergoeding;
- bedrijfswagen en tankkaart;
- hospitalisatie- en groepsverzekering;
- eco-cheques met een max. van 250 euro per jaar;
- de kans om een groot netwerk op te bouwen;
- de mogelijkheid om je ervaring en kennis te delen met andere TEC consultants
Deze opdracht kan ook als freelancer uitgevoerd worden:
- Betalingstermijn van 15 dagen na factuurdatum
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