EMO Quality Operation Alternant
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Job Location:
Monthly Salary:
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Title:
EMO Quality Operation AlternantCompany:
Ipsen Pharma (SAS)About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!
For more information visit us at follow our latest news on LinkedIn and Instagram.
Job Description:
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
Nous nous engageons à créer un lieu de travail où chacun se sent écouté valorisé et soutenu où nous incarnons The Real Us*. La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de linclusion et de légalité des chances. Lorsque nous intégrons des modes de pensée diversifiés nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin daménagements ou daide pendant le processus de candidature veuillez en informer léquipe de recrutement. Ces informations seront traitées avec soin et nauront aucune incidence sur le résultat de votre candidature. *Soyons nous-même
About Company
Ipsen is a global biopharmaceutical company focused on innovation and specialty care to improve the lives of patients around the world.
