Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Validation Engineer CSV
Scope of work:
- You will develop, implement, and execute of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
- You will develop, implement, and execute validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- You will generate validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
- You are responsible for the validation documentation through approval and implementation.
- You perform 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.
- You will ensure that the Validated Status of computerized systems is in compliance with cGMP at all times.
- You will ensure projects (moderate scale & complexity) are managed in conjunction with all required Sanofi and cGMP regulatory standards.
- You will keep 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.
- You will provide input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
- You will investigates/troubleshoots moderately complex validation problems.
Profile:
- You have Strong communication skills
- You are capable to work independently and learns fast
- You are able to execute project to plan
- You have competent knowledge of Computer Systems Validation
- You are full understanding of relevant quality and compliance regulations
- You are capable of troubleshooting validation issues
- You have minimum of 3 years’ experience working in a pharmaceutical sector and GMP environment
- You have a good knowledge of English and Dutch
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Are you interested? Apply now!
