Data Integrity Manager
WHAT ARE YOUR RESPONSIBILITIES?
- You will manage the DI compliance on all GxP Computerized Systems – Instruments and Equipment
- You will lead Data Integrity Rollout strategy at the respective site
- You will direct the efficient and effective execution of Data Integrity requirements across the site/campus
- You will liaison with relevant cross-functional team ( DI Site program managers globally, mfg sites, R&D, IT, other) to coordination DI activities to leverage scale and maximize efficiencies accordingly.
- You will collaborate with other DI site program managers to share best practices and harmonized processes across the global mfg sites
- You will Resolve timeline issues related to executional deliverables and develops tactical plans when necessary to bring back on track.
- You will ensure Day to Day discipline to project plan and call out any risk of timeline gaps
- You will ensure implementation of continuous improvement and process improvements programs
- You will ensure adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.
WHO ARE WE LOOKING FOR?
- You have an University degree in a technical discipline (e.g Engineering, Science, Information Technology)
- You have more than 5 year’s relevant experience with GMP processes, computer systems & data.
- You have good Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)
- You have good Knowledge of FDA validation and CFR 21 Part 11
- You have good knowledge of various software applications and SAP ERP is a plus
- You have the ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
- You have experience in supply chain processes and systems
- You have knowledge of data integrity requirements
- You are an excellent team player with strong analytical skills, negotiating and communication skills
- You are communicative and writing strong in both Dutch and English
WHAT DOES QBD OFFER YOU?
- A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all…
- Working for the Flemish Young Entrepreneur of 2019!
- A flat organization in the broadest sense of the word
- An increase in your IQ thanks to our extensive training package
- A hip office with air hockey table
- More muscle mass through our weekly boot camps
- 32 vacation days that you wish were fewer (because it's great to work here ? )
- A job with long term perspectives for further growth
Interested? Apply now by sending us your CV and motivation.