QC Assistant (H/F)
Description de la fonction
- Establish and carry out the quality controls required to ensure the quality of finished products and meet customer expectations and meet legal requirements.
- Carry out all necessary controls during IMP production activities.
- Verify that the appropriate validation/qualification has been done before giving the greenlight to start IMP production activities.
- Write the specifications for the starting material and for packaging material purchased by CSM.
- Write sampling instructions or other Quality Control procedures.
- Control, approve or reject starting material and/or packaging material.
- Perform Batch Record Review pre and post production.
- If required, take representative samples of the batch for analysis or for retention (before, during, after packaging).
- Verify the conformity of retention samples to ensure that products are conform.
- Verify the conformity of text for the model labels printed at CSM/label proofs provided by supplier to ensure the labels are conforms with the local regulation.
- Check the labels/code breaking envelopes printed by CSM.
- Ensure that a timely and effective communication and escalation process exists in case of quality issues.
- Contributes to the quality department's activities to ensure continuity of operations.
- High organizational and planning skills
- French and English; any additional language is an asset.
- Good dose of assertiveness.
- Statistical knowledge
- Analytical mind
- Good computer skills : Word, Excel, Outlook, PowerPoint...
- Team worker and team spirit
- Customer oriented
- Excellent communication and intercultural skills
- A critical eye for details; not taking things for granted
- Open minded but critical and analytical reasoning
- Sufficient authority or influence on collaborators
- Able to interpret in process control (IPC) results generated by production staff
Un contrat interim en vue d'engagement !