Contract Length: 12 Months
Looking for a SAP QA/CSV Manager to work with a Global Manufacturing Organisation based in Frankfurt.
- Support the regional "QA/CSV Manager" in order to ensure that processes within computerized systems (e.g. ERP (SAP), Trackwise)
are implemented and used in a compliant manner (GxP) following internal and external regulations.
- Approval of System Life Cycle documentation in compliance to the respective validation methodology.
- Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise (minimum of 5 years)
- Must have strong experience of trackwise , SAP , ERP
- Profound knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems -
including external regulations e.g. EU-GMP Guideline, Data Integrity requirements and internal regulations
- Risk Management capabilities (joint risk mapping, risk assessment, risk acceptance and risk communication)
- Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements
- Fluent in English (writing and verbal), preferable one additional regional key language.
Please note lots of travel is involved!!
SAP / ERP / CSV / QA / Quality / GMP / GxP / system life cycle / trackwise