Quality Operation Alternant – External Manufacturing
• Quality Event:
o Manage quality event received from CMO and record them in the relevant Ipsen database
according to local procedure.
o Manage quality event related to the activity of its department
o Evaluate the investigation report to assure that criticality, root cause, impacts and CAPA are
properly addressed.
o Evaluate the CMO decision regarding the final disposition of the impacted batch(es) and
confirm the Ipsen decision to the CMO.
o Escalade the event when relevant
o Manage CAPA requiring Ipsen monitoring in the relevant database
• QC :
o Manage OOS received from CMO and record them in the relevant Ipsen database according to
local procedure.
o Coordinate with the technical team for OOS result evaluation & escalation
o Oversee the stability program (on-going & ICH studies)
o Be the focal point for T° excursion issue
• Product/Vendor complaint
o Coordinate the reception of market complaints and the investigation with the CMO
o Ensure the answer to complaint in the defined timelines
o Identify recurrence and actions of improvement if necessary
o Identify the complaint that need to be escalated and coordinate actions with the CMO
Quality manager for escalation
o Record and manage vendor complaint
• Product Quality Review
o Prepare the data for the annual PQR evaluation
o Contribute to PQR evaluation
• Quality disposition of materials and drug product
o Check master data & approve BOM in SAP
o Review the serialization information and perform necessary actions in Unicity and SAP if
relevant for batch dispositioning
o Be involve in the artwork process and perform the required action in the dedicated system
o Batch review & release documentation preparation
• Other:
o QMS support (operation SOP creation & review)
o Stability tracker implementation & deployment
o Accountable for ad-hoc project completions and achievement of compliance goals
o Participate in GQA audits, inspection if any and self-inspection
| Contrat | : | Alternance |
|---|---|---|
| Lieu de la mission | : | Paris Paris 15 |
| Niveau d'étude | : | Bac + 2 : DEUG, DEUST, classe préparatoire |
| Expérience | : | Débutant |
| Poste(s) disponible(s) | : | 1 |
| Poste de cadre | : | Non |
| Début de la mission | : | Dès que possible |
| Secteur | : | Secteur médical, Santé, Social |
