ID EXISTS
POS 4672
Status 5
DJM 1

Process Validation Expert

Beschreibung: For one of our Austrian Pharma clients we are looking for freelance support as: Processs Validation Expert (M/F/*)
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Tasks:
  • Drug product at CMO 1
  • Support finalization of PPQ repor
  • Support update of PPQ report with data from cumulative hold time batch
  • Review, support, improve other source documents on need basis
  • Support review of BLA modules
  • Diluent at CMO
  • Support preparation of PPQ campaign (review of validation and qualification documents)
  • Support PPQ execution
  • PPQ report review
  • Review, support, improve other PV relevant document
  • Drug product at CMO2
  • Support manufacturing site preparation for first DP batch, GMP batches and PPQ campaign
  • Review of site qualification documents
  • Support development activities and documentation for 420mg dose strength
  • Review, support, improve PV relevant document
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Qualifications:
  • Start: 14.06.2021 // Duration: 8 months // Capacity: 20 hours per week
  • Senior level of expertise in biologic drug product development (Lyophilized, pre filled syringes )/manufacturing
  • Expereinced in process validation, GxP, tech transfer and submission of documents
  • Business fluent in English
Bemerkungen: WANTED: Process Validation Expert (M/F/D). Please contact +49 89 18 90 99 841 or bernic.gebhardt@k-recruiting.com Skills: Drug Developement, Drug Manufacturing, English, GMP (Good Manufacturing Practice), Pharma, PPQ, Process Validation, QA (Quality Assurance), Qualification & Validation, Submission Management, Tech Transfer
K-RECRUITING Life Sciences Personalberatung - parallax image
Interesse geweckt?
Auf geht's!
Beginn: 14.06.2021
Laufzeit: 8 months
Einsatzort: remote
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