Description
Our pharmaceutical client require an experienced CSV Engineer for a Data Integrity Project at their production facility in Budapest, Hungary. They have around 50 computerised systems onsite, mostly process control and some lab systems. They have seen the need to improve data integrity for these systems, in light of recent FDA and EU regulations.Duties/Deliverables:
- Conduct an overall assessment of site systems for data integrity issues.
- Create and define an action remediation plan for site systems and equipment.
- Working together with local resources, oversee the remediation process.
- Establish, coordinate and set up data integrity procedures, processes and policies that efficiently enhance data integrity.
- Successful candidate should have prior experience of implementing data integrity strategy in a pharmaceutical or biopharmaceutical setting (sound knowledge of CGMP).
- Strong previous experience implementing CSV strategies, with solid understanding of 21 CFR 11 and EU Annex 11.
- The ability to communicate effectively, possess good organisational skills, utilise technical procedural writing skill, and be able to work collaboratively in a team environment.
- Self-starter with the ability to work independently.
- Fluent English; speaking, reading and writing (Hungarian NOT required).