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

QA Officer

Entreprise
Kelly Services
Lieu
Suisse romande
Date de publication
10.11.2016
Référence
218682

Description

Kelly Scientific is looking for a QA Officer for our pharmaceutical partner localised in Western part of Switzerland.

Your mission
Work with the Manufacturing, Quality Control and Development departments as Quality Assurance representative to support the following:
  • Review of master batch record and associated documents
  • Closure of deviations, change controls and laboratory investigations related to batch production
  • Review and approve manufacturing batch records and certificate of analysis from QC

Your responsibilities
  • QA representative in NBE production projects, tech transfer, change control and deviations
  • Ensure the review and approval of product master batch record
  • Review and approve product specifications and standard operating procedures
  • Support the evaluation of NBE product manufacturing related deviations, CAPA, change controls, laboratory investigation and internal audit findings
  • Provide support for inspection by authorities, internal and external audits
  • Contribute in the optimization of quality processes based on GMP
  • Perform other relevant duties as required

Your profile
  • BSc, MSc or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline
  • At least 2 years of relevant experience in an industrial setting under GMP manufacturing conditions
  • Relevant experience in biotechnology
  • QA experience and knowledge of current EMEA, FDA, USP, EP and ICH guidelines
  • Fluent English both written and verbal; proficiency in French is highly desirable

Your Kelly contact
Sophie Darthenay
Kelly Services
Consultant Professional Staffing Life Sciences

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