Job Overview:
The role of Near-Infrared Spectrometer Validation Expert involves comprehensive qualification and validation of bench top Near-Infrared (NIR) spectrometers. This encompasses:
* Creating User Requirements Specification (URS) documentation
* Evaluating Good Manufacturing Practice (GMP) compliance
* Managing change control processes
* Supporting vendor-issued Instrument Qualification/Operational Qualification activities
* Developing Near-Infrared models
* Performing Performance Qualification (PQ)
* Creating a Requirements Traceability Matrix (RTM)
* Ensuring Annex 11 compliance
* Generating a Validation Summary Report
This position requires a senior-level candidate with the ability to take ownership of the project, ensuring timely completion and adherence to schedules.
Key Responsibilities:
* Maintaining qualifications in Science, Quality, or a related Technical field
* Working within a GMP manufacturing environment with experience in Pharmaceutical/Biological Quality and Lab function
* Validating laboratory equipment
* Demonstrating effective written and verbal communication skills
Requirements:
* Bachelor's degree in Science, Quality, or a related Technical field
* Strong experience in validating laboratory equipment
* Effective written and verbal communication skills