Validation Support (m/f/n) – 500 h – 12 months – freelance – on-hold

Details

Beschreibung

Technical and validation documentation creation, Vendor-acceptance testing preparation

Objectives:
For this project making a resource is needed to create the required GMP documentation for new process equipment, utility systems and facility extensions. The internal change control process will be followed. The candidate will be working as part of the project team, located in the plant nearby Frankfurt.

Specific Responsibilities/Activities (rough estimate: 500h)
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 the standards of the customer (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 of the customer. 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.

Location and schedule:
• In average 80% presence on-site is required (during installation/testing 100%)
• Travel to suppliers in Europe might be required
• Workload might vary during the execution of the project. During times with low project workload support of other projects might be needed.
• On need basis working on shift basis might be required (e.g. during installations)

Other skills:
• 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:
Start: June/July 2023
Duration: 12 months
Workload: approx. 500 h
Location: Greater Frankfurt/Main
On-site share: approx. 80 %

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