Qualification & Validation Engineer

Service description

• Develops, implements and executes URS, CAT, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small scale

equipment in QC and Manufacturing, including the related software. Develops, implements and executes

validation studies for cGMP-critical process systems to demonstrate compliance with cGMP, user and

regulatory requirements. This role involves hands-on activities.

• Performs qualification of systems in scope where industry precedence exists, but where standards require

case-specific interpretation. Ensures all activities are in accordance with cGMP, cGLP and Sanofi Procedures.

• Ensures that the qualified status of systems in scope is in compliance with cGMP at all times.

• Supports projects in conjunction with all required Sanofi and cGMP regulatory standards.

• Maintains current knowledge 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.

• Takes responsibility for the validation documentation through approval and implementation.

• Provides input in the review and assessment of changes to assess whether they impact the qualified status

and validation documentation, as appropriate.

Profile Requirements

• Knowledge of cGMP requirements in a regulated environment.

• Understanding of relevant quality and compliance regulations.

• Ability to troubleshoot validation issues.

• Good knowledge of quality management systems.

• Experience: 2-4 years working in a healthcare manufacturing environment, with experience in qualification

of small scale equipment (including the related software).