Beschreibung
You are a Data Integrity Specialist and are interested in working as contractor for one of the most renowned pharmaceutical companies? Then you should definitely apply for this position!The expertise you should have:
- Ability to visualise complex processes in a structured and simple way
- Profound understanding of GMP and experience in the (bio)pharma GMP field
- Profound knowledge regarding the validation of computerised systems (equipment, computer systems, spreadsheets), e.g. GAMP5
- Profound knowledge of current regulatory requirements regarding Electronic Records (e.g. Part 11, Annex 11), Data Integrity and computerised systems of the EU and FDA
- Knowledge regarding archiving requirements are an additional asset
- Strong communication skills and team spirit
- Working in multinational project teams
- Fluency in English; German language skills would be advantageous
Project tasks you would deal with:
- Process depiction
- Active support regarding the entry, depiction and analysis of production, laboratory and supporting processes (e.g. maintenance) as well as their data flows in so-called Data Maps
- Leading and participating in Data Mapping Workshops
- Recording and evaluation of potential deficits regarding data integrity topics
- Data integrity
- Coordination of activities linked to data integrity, e.g. Data Maps within global bio-pharmaceutical sites
- Project work
- Participation in project teams that work out process depictions within the global bio-pharmacy
Details you should know:
- Location: Baden-Wurttemberg, 15% home office, possibly business trips to Austria
- Volume: 142 h/months or rather 35 h/week
- Start date:
- Duration: 9 months
This job description caught your attention? Then send me your up-to-date CV and let me know when you are available for the job.
I am looking forward to hearing from you!
Für mehr Informationen über Progressive Recruitment besuchen Sie www.progressiverecruitment.com/de.