Lead QC Method Development & Validation
Croda Singapore
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Benefits offered by this job
Job summary
Croda is seeking a QC Specialist, Method Development and Validation to lead analytical method development, validation, transfer, and lifecycle management. You will act as the technical SME for methodologies, instrumentation, and lab investigations, partnering with QA, Manufacturing, Regulatory Affairs, and external labs.
The role requires eight+ years in GMP-regulated pharma/biotech, strong ICH/Q2 knowledge, and leadership across cross-functional teams.
Qualifications
- Bachelor’s degree in Chemistry or a related field required.
- Eight+ years in a GMP-regulated pharma/biotech environment.
- Experience in analytical method development, validation, transfer.
- Strong knowledge of ICH Q2(R2), USP, FDA, EMA and data integrity.
Responsibilities
- Lead development, validation, transfer, and lifecycle management of analytical methods.
- Author validation and transfer protocols and reports.
- Provide technical leadership to analysts and cross-functional teams.
- Ensure cGMP compliance and data integrity in laboratories.
- Support regulatory submissions and inspections.
Skills
Education
Tools
Job description
Croda is seeking a QC Specialist, Method Development and Validation to lead analytical method development, validation, transfer, and lifecycle management. You will act as the technical SME for methodologies, instrumentation, and lab investigations, partnering with QA, Manufacturing, Regulatory Affairs, and external labs.
The role requires eight+ years in GMP-regulated pharma/biotech, strong ICH/Q2 knowledge, and leadership across cross-functional teams.
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