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Validation Engineer FR / EN

Entreprise
AXEPTA SA
Lieu
Vaud
Date de publication
30.11.2016
Référence
241256

Description

Our client, an International Pharmaceutical Group based in the Canton de Vaud, is looking for an Validation Engineer.

You will join a dynamic team and work on several validation projects? Please send your complete application: CV in English + cover letter + copies of your diplomas.

Validation Engineer FR / EN

Your Responsibilities :

  •  Ensure that all validation activities for the products which they are accountable, are performed and are in line with the current company requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
  •  Write and execute protocols and reports (e.g. launches, transfers, weak point remediation).
  •   Work closely with QC, Production, and Costumer Service to define validation timing and ensure that activities are well planned and followed.
  •  Perform validation sampling in production areas and provide them to QC with the associated documentation.
  •  Ensure that all validation activities are performed and are in line with the current company requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
  •  Translate the critical process parameters and the process control strategy into a focused validation plan for process validation
  •  Manage deviations, CAPAs, change controls related to validation activities. Review Master Batch Records (MBRs).
  • Participate in improvement and remediation of products: provides technical expertise to define and execute product optimization projects and to support manufacturing issues.
  • Master in applying continuous improvement methodology such as problem solving, 5S.
  • Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
  • Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
  • GMP
  • Respect all GxP standards
  • GxP knowledge and (as appropriate) experience to support Health Authorities requirements.

Your Profil: 

  • Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control.
  • In order to effectively and independently own and lead all elements of the Product Lifecycle for a specific product or product family.


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