Quality Assurance Specialist (Validation)
DHL
- Esenyurt, İstanbul
- Sürekli
- Tam zamanlı
- Bachelor’s degree from Science Faculties (Chemistry, Chemical Engineering, Physics etc...)
- Minimum Upper Intermediate level English in both written and spoken.
- Experienced in temperature mapping, transportation vehicles validation, computerized system validation
- Strong knowledge of FDA 21 CFR Part 11 and GAMP5 standards & rules
- Effective using MS Office programs
- No military obligation for male candidates
- Preferably residing near to Esenyurt area.
- Initiating, monitoring and reporting the validations in accordance with the annual validation plan and protocols,
- Updating the validation master document and annual validation yearly plan,
- Updating the SOPs in accordance with the validation results, providing trainings to the responsible team about SOP’s
- Attending both internal & external audits and following up actions about validation
- Executing relevant regulations (GMP, FDA EudraLex and Ministry of Health, GAMP5) with IT activities in available and new facilities,
- Analyzing risk based on Equipment and Software URS
- Keeping track, monitoring and reporting the Data Integrity process of equipment and Software
- Taking part in the control of change and deviation processes of Computerized System.