Job Description
Job Description:
We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods—primarily dissolution and particulate matter testing (USP <788> )—for a GMP release testing laboratory supporting a pharmaceutical compounding facility. The consultant will work alongside an existing chemist trained in UPLC analysis to ensure methods meet regulatory, quality, and operational requirements for routine release testing.
Responsibilities:
We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods—primarily dissolution and particulate matter testing (USP <788> )—for a GMP release testing laboratory supporting a pharmaceutical compounding facility. The consultant will work alongside an existing chemist trained in UPLC analysis to ensure methods meet regulatory, quality, and operational requirements for routine release testing.
Responsibilities:
- Analytical Method Development & Validation.
- Develop, optimize, and validate dissolution methods for various drug products in accordance with USP and ICH guidelines.
- Perform validation of USP <788> particulate matter testing methods, ensuring compliance with regulatory requirements.
- Draft, review, and finalize Method Validation Protocols (MVPs) and Method Validation...
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