Validation Engineer (m/f/n) – Freelance (on hold)

Details

Beschreibung

Tasks:

1. Creations of GMP documentation
• Creation and alignment of validation strategy of the project. Alignment with QA, MPD and R&D team.
• Creation of validation documentation according to standards (DQ, IQ, OQ, PQ, risk assessment …). This includes creation of validation plans and reports.
• Lead the document review and approval process with clear focus on timely completion
• Support the project manager to develop a realistic schedule and update it regularly
• Update of SOPs, if changes caused by project

2. Equipment vendor acceptance testing (VAT) preparation and execution
• The testing of the machine at the manufacturer is key to enable perfect startup at the plant. Thus, detailed preparation is needed to assure efficient execution.
• Creation of test plans for validation documentation
• Execute test plans during VAT and document results
• Confirm if equipment/installation was built according to specifications. Document results.

Requirements:

• Fluent in English and German (verbal and written)
• Experience with GMP and validation requirements is a must
• Experience with industrial making systems is needed

Additional information:

project start: 01.09.2023
project end: 31.08.2024
duration: 12 months
location: greater area Frankfurt a.M.

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