quality supplier senior expert à Aubonne

Adrien Koralsztein, Randstad Merck Aubonne
type d'emploi
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job details

aubonne, vaud
type d'emploi
adrien koralsztein, randstad merck aubonne
058 432 75 88

description du poste

Your role :

Suppliers,subcontractors and materials quality management, including qualification,quality performance monitoring, external audits, change notificationsassessment, quality and technical contracts establishment.

Participate inharmonization projects between sites

To ensureperformance of external audits and Quality and Technical Agreements

To ensureSuppliers/materials continuous qualification and monitoring ( changesassessment, initial and continuous qualification, monitoring).

Direct communicationwith suppliers

To manageSupplier/materials qualification and monitoring according to any applicableexternal and internal regulations.

To continuouslyimprove the process and update the SOPs related to Supplier/material qualitymanagement.

To establish localstandards, Qualification report and monitoring of suppliers and serviceproviders, Quality and Technical Agreements and specifications.

To manage andperform external audits.

To manageNonconformance and CAPA (Corrective Actions / Preventive Actions) linked toSupplier / Material.

To manage ofSupplier Change Notifications.

To perform internalaudits.

To perform Qualityrisk analyses.

To participate intraining people on Supplier/material quality activities.

In case of absencethe responsibility of the job is escalated to the Quality Assurance SuppliersQuality Manager.


Your profile :

Expertise in cGMPbest practices and ISO quality management systems.

Expertise inperforming supplier and internal audits.

To be recognizedwithin the Company as a subject matter expert with respect to theaccountability areas.

To ensure up to dateQuality Assurance best practices in line with pharmaceutical industry cGMP's

Expertise in writingQuality and Technical agreements

Expertise inassessing materials/suppliers changes

Expertise inqualifying new materials/suppliers

Chemistry, biologyor pharmacy university degree or equivalent experience

Experience inQuality Assurance/Quality Control and specifically in suppliers managementExperience in Health Authorities inspections (Swissmedic, EMA, FDA)