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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.

Responsibilities 
  • 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.

Requirements 
  • 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.

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

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