Post Jobs
Life Sciences Stellen Basel

Validation Expert, 100% (f/m)

Temporärstelle
Einritt: asap
Region: Basel
Stelle: Life Sciences
Art: Temporärstelle

Pharmaceutical company needs reinforcement.

asap

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

Validation Expert, 100% (f/m)

Major Accountabilities

  • 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

Requirements

  • 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

Für Fragen

In case of any questions, please don’t hesitate to contact Renato Imboden at 061 269 90 60.

Unser aktuelles Stellenangebot: www.edp-basel.ch / www.stellen-basel.net

Sie können uns Ihre Bewerbung mit diesem Formular oder auf info@edp-basel.ch zusenden.

Wir freuen uns auf Ihre Bewerbung.

Bitte vollständige Bewerbung (Lebenslauf, Zeugnisse, Diplome). PDF-Dateien bevorzugt.

Zurück zum Stellenangebot