CSV expert for FDA readiness (Freelance) (m/w/d)
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Hamburg, Deutschland |
Freelance
Job title: CSV expert for FDA readiness (Freelance) (m/w/d)
Industry: PharmaSkills: CSV, FDA Inspektion, SOP
Start of project: ASAP
Duration of the project : 4 Months
Project volume: full time
Location: Hamburg , on site
Tasks:
- Bringing systems documentation of validation and qualification activities for laboratory and (pharmaceutical or biotechnological) production computer systems into line with SDLC and CFR21
- Revise methodology for computerized systems validation (CSV)
- Create SOPs on how to carry out validations and train staff
- Update the Site Validation Master Plan
- Support Workstream Lead in coordinating systems validations and carrying out the qualification of service providers and supplier
Qualifications:
- good experience within the Biotech environment
- very good CSV knowledge
- lot of experience with FDA inspections
- fluent in English and German
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Natascha Urban
n.urban@aristo-group.com
+49 89 599 1827 200
11291
Pharma
ab sofort
4 Monate
Freelance
