Full Description

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).

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