Beschreibung
Project / FREELANCE - Computer System Validation Pharma Industry / Hesse, Germany / 1 YearFor an international pharmaceutical consultancies we are currently looking for a freelance/contract computer system validation specialist.
This role will be with a pharmceutical client based in Frankfurt, Germany.
Duration: 1 year full-time (minimum 80% on-site).
User Requirements, Validation plans, Risk Assessments, Protocols. Prepare validation documents
Execute validation protocols (IQ/OQ/PQ).
Develop SOPs and training manuals.
Assist users with SOPs and trainings.
Develop Final Documents and close projects (Tracematrixes, Summary reports)
Perform administration, monitoring, troubleshooting and upgrades to the corporate File, Printing, Internet access, Web and E-mail services.
Conducting validation activities at client sites.
Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP). Complete assigned projects and tasks within agreed deadlines.
Final Report writing at the conclusion of the validation project. Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance.
Needed: Bachelor's or Masters Degree in Electrical Engineering or Computer Science and have a minimum of 5-7 years experience in pharmaceutical industry -
In particular with production, computerized lab equipment such as microscopes, spectormeters, analyzers, packaging and labeling, engineering or IT.
Working knowledge of regulations (cGMP - FDA 21CFR Part 11, Good Automated Manufacturing Practice (GAMP4), GLP and Good Automated Laboratory Practice (GALP)) and current industry practices in hardware/software validation and computerized systems such as SAP, LIMS, automated DCS, BMS, Delta V etc.
German and English fluent must have!
I am happy to provide some more information and am looking forward to receiving your latest CV stating availability and expected pay rate.
This is quite urgent so I recommend to answer by email or give me a call as soon as you can.
Mit freundlichen Grüßen / Kind regards
Roland Knoefel
Quality Assurance
QA / QP / GxP / Audits / QC / FDA Readiness
Consultant, Central Germany, Freelance Division
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