/ L'annuaire des offres d'emploi en Suisse Romande

GMP Application Manager

Entreprise
Kelly Services
Lieu
Suisse romande
Date de publication
04.11.2016
Référence
227298

Description

Kelly Scientific is looking for a pharmaceutical company localized in the Vaud area of Switzerland: an Application GMP Manager (Temporary mission – start ASAP - 4 months - potential extension).
 
Your missions
IT tools management implementation of CRTS and Trackwise within subcontractor to ensure compliance with global and intern processes and procedures
Maintenance of highest standards within multiple European subcontractors in order to ensure electronic records in both the above systems are opened, managed and closed according to procedures 
Generation of creative solutions for technical problems
Support establishment of TTS/QAA for supply and release of products
Subcontractors Quality key objectives support: quality improvement
 
Your responsibilities
Maintain effective Quality Assurance systems to ensure that subcontractors operations are in full compliance with Global standards and policies, GMP, GDP and regulatory requirements by performing the following of:
  • Quality Complaints
Set up or maintenance of an effective complaints management process in place
Help in critical complaints and incident management procedures link determination
Product Quality Complaints management with CRTS tool
  • Change Control
Set up or maintenance of an effective management of change control (new pack introduction, product discontinuation, major pack changes, re-packing activities)
  • Corrective and Preventive Actions (CAPA) and Deviations
Set up or maintenance of an effective management of Deviations
Root cause analysis follow-up, investigation and CAPAs follow-up
Trackwise records follow-up
  • Subcontractors Quality Agreements
TTS/QAA execution coordination for supply and release of products
TTS/QAA checks hard copies archiving
 
Your profile
  • Graduate in Chemistry, Pharmacy or another related science
  • Minimum 2 years in pharmaceutical industry
Experience in QA, in quality system
  • Fluent in English is required
 
Your contact
Sophie Darthenay
Consultant Professional Staffing Life Science
Kelly Scientific Geneva

 

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