Validation Expert, 100% (f/m)
EDP Personalberatung GmbH
Basel, CH
vor 3 Tg.

Our customer, a pharmaceutical company near Basel, needs reinforcement. For a temporary employment we are looking for a

Validation Expert, 100% (f / m)

Aufgaben

  • Support writing and maintaining Validation Master Plan for process, cleaning and packaging validation
  • Support the strategy for continued process verification (CPV) and annual monitoring batches that ensures all critical process parameters and quality attributes are defined after validation activities.
  • Contributes to risk assessments for CPV

  • Set local procedures & templates for respective validation processes, documentation and validation master plan, create assessments on component criticality
  • Maintain all responsible activities and projects in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.
  • g. no critical observations related to validation activities

  • Leads, facilitates, elaborates and authors risk assessments for validation together with the site validation team (PU, QC, QA) and external functions (TRD, DRA)
  • Ensures that all respective validation activities are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-
  • validation and validation resulting from launch projects as well as major or complex changes

  • Authors and reviews process, packaging or cleaning validation protocols (e.g. launches, transfers, weak point remediation) and related reports, proposes and reviews MBRs and associated change controls.
  • Supports the execution at the shop floor

    Anforderungen

  • BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
  • Fluent in English and in local language
  • Several years experience in manufacturing / manufacturing science and technology / technical development / Quality
  • Thorough understanding of manufacturing processes and related process equipment
  • Strong working knowledge of quality systems and regulatory requirements across multiple health authorities
  • Experience in executing process validation
  • Expert in reviewing and writing technical reports
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
  • Fundamental understanding of standard pharmaceutical analytical testing
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