QA Validation Engineer

at  MindCapture

JOB DESCRIPTION

As QA validation engineer, you are responsible for the development, implementation and execution 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.

• 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 Procedures.
• Ensures that the Validated Status of computerized systems in scope is in compliance with cGMP at all times.
• Ensures projects are supported in conjunction with all required 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.
• We are looking for someone who has validation experience in documenting validation activities using Kneat paperless validation software.
• Be able to give support how to use Kneat paperless validation software.
• Data migration and transformation of validation documentation must be performed.

REQUIRED COMPETENCES & SKILLS

• 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
• Experienced knowledge of Kneat paperless validation software
• Be able to give training and support regarding Kneat
• You are flexible and a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
• You like to work in team and consider yourself to be a good team player
• Good knowledge of English and Dutch.

• 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 Procedures.
• Ensures that the Validated Status of computerized systems in scope is in compliance with cGMP at all times.
• Ensures projects are supported in conjunction with all required 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.
• We are looking for someone who has validation experience in documenting validation activities using Kneat paperless validation software.
• Be able to give support how to use Kneat paperless validation software.
• Data migration and transformation of validation documentation must be performed