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QA - Method Validation

QA - Method Validation

LocationGeleen , Netherlands
Business SectorBiotechnology
Contact email
Job ref23335
Publishedabout 1 month ago
QA Specialist - Process and Method Validation 

Job Description 
  • QA Specialist Process, Method & Shipping Validation reviews and approves documentation and oversees qualification / validation/verification of QC analytical methods, validation of manufacturing, cleaning, disinfection and shipping processes.
  • He/she reviews and approves the validation documents required to ensure the compliant analytical, manufacturing and shipping process and provides validation knowledge support to the project when required.
  • He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied.

  • Overseeing Method and Process verification / qualification / validation deliverables.
  • Review and approve the process performance qualification (PPQ) Readiness plans.
  • Review and approve process FMEA for the assessment of process parameters.
  • Review and approve the risk assessments related to Method and Process validation.
  • Review and approve process control strategy and reports.
  • Review and approve all prerequisites  prior to the various stages of the product life cycle.
  • Review and approve process validation plans;
  • Review and approve PPQ protocols and reports .
  • Ensure Continuous Process Verification (CPV) for products at various stages.
  • Review and approve method validation master plan and matrix.
  • Review and approve test method validation protocols and reports.
  • Ensure the correct application of the validation requirements.
  • Ensure correct implementation of global disinfectant efficacy study on site.

  • Knowledge and understanding of cGMPs, ICH Regulations, FDA Guidelines, US and EU Pharmacopoeia and validation practices and their application in practice.
  • Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system.
  • Support the production & technical services teams in the implementation of the validation activities.
  • Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be compliance oversights).
  • Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Contributes to long-term strategic development of validation program and related plans and projects related to method, process, cleaning and disinfection and shipping validation.
  • Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up.
  • Own QA related quality system deliverables (CAPA, Change Control) and use project management skills to coordinate the related activities, drive timely results for successful milestone completion and limit compliance risks.

  • Location: Geleen, The Netherlands
  • Start-date: ASAP 
  • Permanent contract 

Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her on +31 2020 44502.