Validation Consultant (8 months)
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology, Medical Devices and Pharmaceutical organization, based in Genf Switzerland.
The company is a Class II Medical Devices company, adhering to both ISO 13485 and FDA 21 CFR 820 regulations.
You will plan, schedule and realize validation projects in accordance with the Validation Master Plan. Next to this, you will plan, schedule and realize Measurement System Analysis (MSA) / Gage R&R studies to evaluate the measurement systems. This will be including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGMP requirements. You will be responsible for improving the incoming inspection traceability.
- Validation activities
- Maintain and update all documentation pertaining to qualification and validation
- Plan and schedule validation projects
- Plan and schedule Gage R&R studies
- Generate and execute validation protocols IQ, OQ, PQ and Gage R&R studies
- Maintain records for analysis
- Document test results
- Assist in documenting and resolving deviations encountered during execution of validation activities
- Make adjustments to equipment or processes that require improvement
- Prepare validation summary and final reports
- Incoming Inspection activities
- Create and update the inspection forms
- Update the SAP inspection plan
- Identify the measurement equipment to control the critical dimensions
- Knowledge of FDA regulations and GMPs; Knowledge and understanding of FDA regulations, 21CFR Part 11 requirements and cGMPs.
- Familiar with facilities and equipment, utilities, calibration, IQ, OQ, PQ
- Experience in writing and executing protocols for process validation and computer controlled systems validation.
- Working knowledge of validation test instruments and equipment.
- Experience with the following processes and equipment:
• Glue Dispensing
• Grease Dispensing
• Potting Process
• Ultrasonic Welder
• Soldering Iron
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.