For our client - a biotech CMO in Geleen, The netehrlands - I am looking for a QA Specialist with expertise in Process and Method Validation to join a dynamic team!
- 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: 1 September 2023
- Permanent contract
Send your CV to Khanyi Mabena at email@example.com or contact her on +31 2020 44502.