EMO Quality Operation Alternant

Title:

EMO Quality Operation Alternant

Company:

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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and 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 l'inclusion et de l'égalité 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 d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même