Cleaning Validation Specialist (API)

Dortmund  ‐ Onsite
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Description

Cleaning Validation Specialist (API)
Dortmund
6m Contract
€70 per hour

Optimus Life Sciences is working with a Pharmaceutical client located in North Eastern Germany to hire a Cleaning Validation Specialist for a 6-month on-site project. The successful candidate must be experienced enough to work at a senior level and have prior exposure to working on a multi-API site.

Responsibilities
  • Development, review, execution, reporting and approval of validation protocols and other validation documents (IQ/OQ/PQ, Summary Reports, etc.).
  • Provide project updates, escalating issues.
  • Assist the customer in meeting project schedule.
  • Provide accurate estimates for validation deliverables.
  • Work with cross-functional core team to ensure all required deliverables are met.
  • Look for a VE to complete mixture of validation; Facilities, Utilities, Equipment, Aseptic Production, Cleaning Validation, Process Validation.


Requirements
  • 5+ years cleaning validation experience.
  • Experience working on a multi API site is a massive advantage.
  • Previous presentations to the IMD or FDA is an advantage.
  • Experience in risk management is an advantage.
  • Knowledge and explanation of the full documentation during validation.
  • Medical device/pharmaceutical/biotech industry experience needed.


If you're interested in applying for this role, please send a CV to for more detail - thanks!
Start date
08/2018
From
Optimus Search GmbH
Published at
10.07.2018
Project ID:
1595536
Contract type
Freelance
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